Treatment Outcome of Auditory and Frontal Dual-Site rTMS in Tinnitus Patients and Changes in Magnetoencephalographic Functional Connectivity after rTMS: Double-Blind Randomized Controlled Trial

Background: Recently, the role of neural modulation in nonauditory cortices via repetitive transcranial magnetic stimulation (rTMS) for tinnitus control has been emphasized. It is now more compelling to consider these nonauditory cortices and the whole “tinnitus network” as targets for tinnitus treatment to achieve a better outcome. Objective: We aimed to investigate the effects of active dual-site rTMS treatment in tinnitus reduction using a double-blind randomized controlled trial. Method: In study 1, the dual-site rTMS treatment group (n = 17) was treated daily for 4 consecutive days. The sham group (n = 13) also visited the clinic for 4 days; they received sham treatment for the same duration as the dual-site rTMS treatment group. In study 2, the rTMS treatment protocol was exactly the same as in study 1. Magnetoencephalography recordings were performed before and 1 week after the last rTMS treatment. The outcome measure was the Tinnitus Handicap Inventory (THI) score and the visual analog scale score. The effects of treatment were assessed 1, 2, 4, and 8 weeks after rTMS treatment in study 1. Then the mean band power and network changes were compared between pre- and post-treatment values after rTMS in study 2. Result: Patients in the dual-site rTMS treatment group exhibited significantly improved THI scores at 2, 4, and 8 weeks after rTMS treatment compared with the pretreatment scores. However, the sham group did not show any significant reduction in THI scores. When the mean band power changes were compared between pre- and post-treatment assessments, an increased oscillation power was observed in the alpha band after rTMS. Conclusion: A beneficial effect of rTMS on tinnitus suppression was found in the dual-site active rTMS group, but not in the sham rTMS group.

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Meta-analysis of randomized controlled trials that assess the efficacy of low-intensity shockwave therapy for the treatment of erectile dysfunction

Therapeutic Advances in Urology ◽

10.1177/1756287219838364 ◽

2019 ◽

Vol 11 ◽

pp. 175628721983836 ◽

Cited By ~ 12

Author(s):

Jeffrey D. Campbell ◽

Bruce J. Trock ◽

Adam R. Oppenheim ◽

Ifeanyichukwu Anusionwu ◽

Ronak A. Gor ◽

...

Keyword(s):

Erectile Dysfunction ◽

Treatment Group ◽

Sham Group ◽

Meta Analysis ◽

Group Versus ◽

Post Treatment ◽

Controlled Trials ◽

Low Intensity ◽

Randomized Controlled ◽

The Mean

Background: The aim of this study was to perform a meta-analysis of randomized controlled trials (RCTs) that evaluate the efficacy of low-intensity extracorporeal shock wave therapy (LiESWT) for the treatment of erectile dysfunction (ED). Materials and methods: A comprehensive search of PubMed, Medline, and Cochrane databases was performed from November 2005 to July 2018. RCTs evaluating efficacy of LiESWT in the treatment of ED were selected. The primary outcomes were the mean difference between treatment and sham patients in the International Index of Erectile Function-Erectile Function (IIEF-EF) domain score 1 month after treatment, and the mean change in IIEF-EF from baseline to 1 month post-treatment. The secondary analysis considered the percentage of men whose erectile hardness score (EHS) changed from <2 at baseline to >3 after treatment. All analyses used a random effects method to pool study-specific results. Results: A total of seven RCTs provided data for 607 patients. The mean IIEF-EF 1 month post-treatment ranged from 12.8 to 22.0 in the treatment group versus 8.17–16.43 in the sham group. The mean difference between the treatment and sham groups at the 1 month follow up was a statistically significant increase in IIEF-EF of 4.23 ( p = 0.012). Overall, five of the seven trials provided data on the proportion of patients with baseline EHS <2 who improved to EHS >3 at 1 month post-treatment. The proportions ranged from 3.5 to 90% in the treatment group versus 0–9% in the sham group and the pooled relative risk of EHS improvement for the treated versus sham group was 6.63 ( p = 0.0095). No significant adverse events were reported. Conclusions: This is the first meta-analysis that evaluates RCTs exploring LiESWT as a treatment modality strictly for ED. This therapeutic strategy appears to be well tolerated with short-term benefits. However further studies exploring specific treatment regimens and long-term outcomes are needed.

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A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial magnetic stimulation of the left prefrontal cortex for depression

Psychological Medicine ◽

10.1017/s0033291707001663 ◽

2007 ◽

Vol 38 (3) ◽

pp. 323-333 ◽

Cited By ~ 52

Author(s):

A. Mogg ◽

G. Pluck ◽

S. V. Eranti ◽

S. Landau ◽

R. Purvis ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Magnetic Stimulation ◽

Sham Group ◽

Rating Scale ◽

Repetitive Transcranial Magnetic Stimulation ◽

Controlled Trial ◽

Randomized Controlled ◽

Real Group ◽

The Mean

BackgroundEffectiveness of repetitive transcranial magnetic stimulation (rTMS) for major depression is unclear. The authors performed a randomized controlled trial comparing real and sham adjunctive rTMS with 4-month follow-up.MethodFifty-nine patients with major depression were randomly assigned to a 10-day course of either real (n=29) or sham (n=30) rTMS of the left dorsolateral prefrontal cortex (DLPFC). Primary outcome measures were the 17-item Hamilton Depression Rating Scale (HAMD) and proportions of patients meeting criteria for response (⩾50% reduction in HAMD) and remission (HAMD⩽8) after treatment. Secondary outcomes included mood self-ratings on Beck Depression Inventory-II and visual analogue mood scales, Brief Psychiatric Rating Scale (BPRS) score, and both self-reported and observer-rated cognitive changes. Patients had 6-week and 4-month follow-ups.ResultsOverall, Hamilton Depression Rating Scale (HAMD) scores were modestly reduced in both groups but with no significant group×time interaction (p=0.09) or group main effect (p=0.85); the mean difference in HAMD change scores was −0.3 (95% CI −3.4 to 2.8). At end-of-treatment time-point, 32% of the real group were responders compared with 10% of the sham group (p=0.06); 25% of the real group met the remission criterion compared with 10% of the sham group (p=0.2); the mean difference in HAMD change scores was 2.9 (95% CI −0.7 to 6.5). There were no significant differences between the two groups on any secondary outcome measures. Blinding was difficult to maintain for both patients and raters.ConclusionsAdjunctive rTMS of the left DLPFC could not be shown to be more effective than sham rTMS for treating depression.

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The Effect of a Transdermal Scopolamine Patch on Postoperative Nausea and Vomiting after Retromastoid Craniectomy with Microvascular Decompression: A Preliminary Single Center, Double-Blind, Randomized Controlled Trial

Journal of Clinical Medicine ◽

10.3390/jcm9010156 ◽

2020 ◽

Vol 9 (1) ◽

pp. 156 ◽

Cited By ~ 3

Author(s):

Hyun Hee Lee ◽

Hyun-Mi Kim ◽

Ji Eun Lee ◽

Young-Tae Jeon ◽

Sanghon Park ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Placebo Group ◽

Microvascular Decompression ◽

Postoperative Nausea ◽

Controlled Trial ◽

Postoperative Nausea And Vomiting ◽

Nausea And Vomiting ◽

Double Blind ◽

Randomized Controlled ◽

The Mean

Background: We performed this prospective double-blind randomized controlled trial to identify the effect of a preoperative prophylactic transdermal scopolamine (TDS) patch on postoperative nausea and vomiting (PONV) after retromastoid craniectomy with microvascular decompression (RMC-MVD). Methods: We recruited 38 patients undergoing RMC-MVD and randomized them into two groups: the TDS group (n = 19, application of the TDS patch) and placebo group (n = 19, application of a sham patch). Nausea (as a self-reported 100-mm visual analog scale (VAS) score; range, 0 (no nausea) to 10 (worst nausea)), vomiting, and the use of antiemetics were the primary endpoints. Results: There was no significant difference in terms of the incidence of PONV (73.7% in the TDS group and 78.9% in the placebo group; p = 1.00) between the groups. However, the mean nausea VAS score was significantly different at arrival to the general ward (0.93 ± 1.71 in the TDS group vs. 2.52 ± 2.85 in the placebo group; p = 0.046), and throughout the study period (0.03 ± 0.07 in the TDS group vs. 0.44 ± 0.71 in the placebo group; p = 0.029). Rescue antiemetics were more frequently used in the placebo group than in the TDS group (9 (47.4%) vs. 2 (10.5%), respectively; p = 0.029). The mean number of antiemetics used throughout the study period was significantly higher in the placebo group than in the TDS group (1.37 ± 2.19 vs. 0.16 ± 0.50, respectively; p = 0.029). Conclusions: The preoperative prophylactic use of a TDS patch was safe and effective in the management of PONV after RMC-MVD in terms of the severity of PONV and the use of rescue antiemetics.

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Psychodynamic therapy for adolescents suffering from co-morbid disorders of conduct and emotions in an in-patient setting: a randomized controlled trial

Psychological Medicine ◽

10.1017/s003329171300278x ◽

2013 ◽

Vol 44 (10) ◽

pp. 2213-2222 ◽

Cited By ~ 12

Author(s):

S. Salzer ◽

C. Cropp ◽

U. Jaeger ◽

O. Masuhr ◽

A. Streeck-Fischer

Keyword(s):

Randomized Controlled Trial ◽

Treatment Group ◽

Controlled Trial ◽

Academic Failure ◽

Psychodynamic Therapy ◽

Post Treatment ◽

Control Group ◽

Global Severity Index ◽

Randomized Controlled

BackgroundCo-morbid disorders of conduct and emotions can be regarded as childhood antecedents of further negative developments (e.g. manifestation of personality disorders in adulthood). We evaluated a manualized psychodynamic therapy (PDT) for adolescents with these co-morbid disorders.MethodIn a randomized controlled trial (RCT), 66 adolescents diagnosed with mixed disorders of conduct and emotions (F92 in ICD-10) were randomly assigned to a manualized in-patient PDT group or a waiting list/treatment-as-usual (WL/TAU) control condition. Diagnoses according to DSM-IV were also documented. Patients were compared using rates of remission as the primary outcome. The Global Severity Index (GSI) and the Strengths and Difficulties Questionnaire (SDQ) were used as secondary measures. Assessments were performed at baseline, post-treatment and at the 6-month follow-up.ResultsThe sample consisted of severely impaired adolescents with high rates of further co-morbid disorders and academic failure. Patients in the treatment group had a significantly higher rate of remission [odds ratio (OR) 26.41, 95% confidence interval (CI) 6.42–108.55, p < 0.001]. Compared with the control group, the PDT group resulted in significantly better outcomes on the SDQ (p = 0.04) but not the GSI (p = 0.18), with small between-group effect sizes (SDQ: d = 0.38, GSI: d = 0.18). However, the scores of patients treated with PDT were post-treatment no longer significantly different from normative data on the GSI and within the normal range on the SDQ. The effects in the treatment group were stable at follow-up. Furthermore, most patients were reintegrated into educational processes.ConclusionPDT led to remarkable improvement and furthered necessary preconditions for long-term stabilization. In future, PDT should be compared to other strong active treatments.

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Circulating Ionized Magnesium: Comparisons with Circulating Total Magnesium and the Response to Magnesium Supplementation in a Randomized Controlled Trial

Nutrients ◽

10.3390/nu12010263 ◽

2020 ◽

Vol 12 (1) ◽

pp. 263 ◽

Cited By ~ 3

Author(s):

Mary R. Rooney ◽

Kyle D. Rudser ◽

Alvaro Alonso ◽

Lisa Harnack ◽

Amy K. Saenger ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Adult Population ◽

Biologically Active ◽

Double Blind ◽

The Public ◽

Randomized Controlled ◽

The Mean ◽

Using Data ◽

Intent To Treat

Ionized Mg (iMg) is considered the biologically active fraction of circulating total Mg (tMg). It is possible that iMg may be a more physiologically relevant marker than tMg. Using data from a double-blind pilot randomized controlled trial, we tested (1) whether oral Mg supplementation will increase iMg concentrations compared with placebo and (2) the relationship between iMg and tMg at baseline. Additionally, we evaluated the agreement between iMg measured in fresh whole blood versus stored samples. A total of fifty-nine participants were randomized 1:1 to oral Mg supplementation (400 mg/day, Mg Oxide) or placebo for 10 weeks. Fasting blood samples were obtained at baseline and follow-up. The analysis used linear regression and an intent-to-treat approach. Participants were generally healthy, the mean age was 62, and 73% were female. The baseline iMg and tMg were modestly and positively associated (r = 0.50). The ratio of baseline iMg to tMg was 64%. The mean supplement effect on iMg was 0.03 mmol/L (95% CI:0.01, 0.05) for Mg supplementation versus placebo. The supplement effect on iMg was not statistically significantly different according to baseline iMg status (above/below median). Compared to fresh blood, iMg was consistently higher in refrigerated and frozen samples by 0.14 and 0.20 mmol/L, respectively. In this relatively healthy adult population, Mg supplementation over 10 weeks resulted in increased iMg concentrations. Whether iMg is a more appropriate measure of Mg status than tMg, and the public health or clinical utility of measuring iMg remains to be determined.

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Electroacupuncture for post-stroke overactive bladder: a multi-centre pilot randomized controlled trial

Acupuncture in Medicine ◽

10.1177/0964528420925488 ◽

2020 ◽

pp. 096452842092548

Author(s):

Haiyong Chen ◽

Changde Wang ◽

Minjie Zhou ◽

Pui Yan Chan ◽

Lo Lo Yam ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Treatment Group ◽

Overactive Bladder ◽

Controlled Trial ◽

Post Treatment ◽

Secondary Outcome ◽

Control Group ◽

Bladder Diary ◽

Post Stroke ◽

Randomized Controlled

Background Although acupuncture has been shown to be effective at treating overactive bladder (OAB) following stroke, to our knowledge, no randomized controlled trial (RCT) examining the effects of acupuncture on patients with post-stroke OAB has been conducted. The aim of this preliminary study was to explore the effects of electroacupuncture (EA) in the treatment of post-stroke OAB. Methods This study was a multi-site randomized, assessor-blind, controlled pilot trial of patients with post-stroke OAB. In all, 34 post-stroke subjects (mean age: 71.0 years; 32.4% female) with OAB symptoms were randomly assigned to the treatment group or control group in a 1:1 ratio. The subjects in the treatment group were treated with six sessions of EA for 4 weeks, while the subjects in the control group received usual care. The primary outcome measure was the overactive bladder symptom scale (OABSS). Secondary outcome measures included a three day bladder diary and the stroke-specific quality-of-life scale (SSQoL). Results EA showed a moderate effect size (ES) on the perceived severity of OAB symptoms as measured by the OABSS at week 5 (one week post-treatment, ES 0.57; p = 0.034) and week 8 (three weeks post-treatment, ES 0.60; p = 0.021), although the results did not remain statistically significant after Bonferroni correction for multiple testing. No significant differences in bladder diary parameters or SSQoL score were found. The EA treatment was well tolerated by the post-stroke subjects. Conclusion A six-session EA treatment was feasible and appeared to reduce OAB symptoms in post-stroke patients. Further fully powered trials are warranted to confirm the efficacy of EA for those with post-stroke OAB.

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A double-blind randomized controlled trial of management of recurrent nosebleeds in children

Otolaryngology ◽

10.1016/j.otohns.2009.01.017 ◽

2009 ◽

Vol 140 (5) ◽

pp. 670-674 ◽

Cited By ~ 17

Author(s):

Nicholas Calder ◽

Swee Kang ◽

Lyndsay Fraser ◽

Tash Kunanandam ◽

Jennifer Montgomery ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Treatment Group ◽

Silver Nitrate ◽

Controlled Trial ◽

Active Treatment Group ◽

Control Treatment ◽

Number Needed To Treat ◽

Double Blind ◽

Randomized Controlled ◽

Receive Treatment

Background: To establish whether a treatment regimen of silver nitrate cautery and 4 weeks of antiseptic nasal cream is superior to antiseptic cream treatment alone in the management of pediatric epistaxis. Study Design: Double-blind randomized controlled trial. Subjects and Methods: Children with epistaxis and visible anterior septal vessels were invited to participate. Patients were randomized to receive treatment or control. Treatment patients received silver nitrate cautery, followed by antiseptic cream for 4 weeks. Control patients received sham cautery followed by antiseptic cream for 4 weeks. Results: A total of 109 patients were randomized and results were available for 93 (85%). Of those receiving cautery, 21 (45.7%) of 46 had no bleeding in the 4 weeks before follow-up. Of those receiving only antiseptic cream 14 (29.8%) of 47 had no bleeding. (χ2 = 2.49; P = 0.114). More children in the active treatment group had an improvement in their symptoms compared with controls (42 of 46; 91.3%) in the treatment group vs 33 of 47 (70.2%) controls (χ2 = 6.626; P = 0.01; relative risk reduction = 71 percent, number needed to treat = 4.7). Conclusion: When using subjective improvement in symptoms as the outcome measure, silver nitrate cautery with antiseptic cream twice daily for 4 weeks appears to give a small but statistically significant benefit when compared to antiseptic cream alone.

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Connectivity as a Predictor of Responsiveness to Transcranial Direct Current Stimulation in People with Stroke: Protocol for a Double-Blind Randomized Controlled Trial (Preprint)

10.2196/preprints.10848 ◽

2018 ◽

Author(s):

Ellana Welsby ◽

Michael Ridding ◽

Susan Hillier ◽

Brenton Hordacre

Keyword(s):

Randomized Controlled Trial ◽

Treatment Group ◽

Direct Current ◽

Transcranial Direct Current Stimulation ◽

Controlled Trial ◽

Double Blind ◽

Direct Current Stimulation ◽

Randomized Controlled ◽

Upper Limb Function

BACKGROUND Stroke can have devastating consequences for an individual’s quality of life. Interventions capable of enhancing response to therapy would be highly valuable to the field of neurological rehabilitation. One approach is to use noninvasive brain stimulation techniques, such as transcranial direct current stimulation, to induce a neuroplastic response. When delivered in combination with rehabilitation exercises, there is some evidence that transcranial direct current stimulation is beneficial. However, responses to stimulation are highly variable. Therefore biomarkers predictive of response to stimulation would be valuable to help select appropriate people for this potentially beneficial treatment. OBJECTIVE The objective of this study is to investigate connectivity of the stimulation target, the ipsilesional motor cortex, as a biomarker predictive of response to anodal transcranial direct current stimulation in people with stroke. METHODS This study is a double blind, randomized controlled trial (RCT), with two parallel groups. A total of 68 participants with first ever ischemic stroke with motor impairment will undertake a two week (14 session) treatment for upper limb function (Graded Repetitive Arm Supplementary Program; GRASP). Participants will be randomized 2:1 to active:sham treatment groups. Those in the active treatment group will receive anodal transcranial direct current stimulation to the ipsilesional motor cortex at the start of each GRASP session. Those allocated to the sham treatment group will receive sham transcranial direct current stimulation. Behavioural assessments of upper limb function will be performed at baseline, post treatment, 1 month follow-up and 3 months follow-up. Neurophysiological assessments will include magnetic resonance imaging (MRI), electroencephalography (EEG) and transcranial magnetic stimulation (TMS) and will be performed at baseline, post treatment, 1 month follow-up (EEG and TMS only) and 3 months follow-up (EEG and TMS only). RESULTS Participants will be recruited between March 2018 and December 2018, with experimental testing concluding in March 2019. CONCLUSIONS Identifying a biomarker predictive of response to transcranial direct current stimulation would greatly assist clinical utility of this novel treatment approach. CLINICALTRIAL Australia New Zealand Clinical Trials Registry ACTRN12618000443291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000443291 (Archived by WebCite at http://www.webcitation.org/737QOXXxt) REGISTERED REPORT IDENTIFIER RR1-10.2196/10848

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