scholarly journals Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Clara Sanches ◽  
Richard Levy ◽  
Sarah Benisty ◽  
Lisette Volpe-Gillot ◽  
Marie-Odile Habert ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Semantic Dementia ◽  
Therapeutic Effects ◽  
Double Blind ◽  
Temporal Lobes ◽  
Time Points ◽  
Direct Current Stimulation ◽  
Cathodal Tdcs

Abstract Background Semantic dementia is a neurodegenerative disease that primarily affects the left anterior temporal lobe, resulting in a gradual loss of conceptual knowledge. There is currently no validated treatment. Transcranial stimulation has provided evidence for long-lasting language effects presumably linked to stimulation-induced neuroplasticity in post-stroke aphasia. However, studies evaluating its effects in neurodegenerative diseases such as semantic dementia are still rare and evidence from double-blind, prospective, therapeutic trials is required. Objective The primary objective of the present clinical trial (STIM-SD) is to evaluate the therapeutic efficacy of a multiday transcranial direct current stimulation (tDCS) regime on language impairment in patients with semantic dementia. The study also explores the time course of potential tDCS-driven improvements and uses imaging biomarkers that could reflect stimulation-induced neuroplasticity. Methods This is a double-blind, sham-controlled, randomized study using transcranial Direct Current Stimulation (tDCS) applied daily for 10 days, and language/semantic and imaging assessments at four time points: baseline, 3 days, 2 weeks and 4 months after 10 stimulation sessions. Language/semantic assessments will be carried out at these same 4 time points. Fluorodeoxyglucose positron emission tomography (FDG-PET), resting-state functional magnetic resonance imaging (rs-fMRI), T1-weighted images and white matter diffusion tensor imaging (DTI) will be applied at baseline and at the 2-week time point. According to the principle of inter-hemispheric inhibition between left (language-related) and right homotopic regions we will use two stimulation modalities - left-anodal and right-cathodal tDCS over the anterior temporal lobes. Accordingly, the patient population (n = 60) will be subdivided into three subgroups: left-anodal tDCS (n = 20), right-cathodal tDCS (n = 20) and sham tDCS (n = 20). The stimulation will be sustained for 20 min at an intensity of 1.59 mA. It will be delivered through 25cm2-round stimulation electrodes (current density of 0.06 mA/cm2) placed over the left and right anterior temporal lobes for anodal and cathodal stimulation, respectively. A group of healthy participants (n = 20) matched by age, gender and education will also be recruited and tested to provide normative values for the language/semantic tasks and imaging measures. Discussion The aim of this study is to assess the efficacy of tDCS for language/semantic disorders in semantic dementia. A potential treatment would be easily applicable, inexpensive, and renewable when therapeutic effects disappear due to disease progression. Trial registration ClinicalTrials.gov NCT03481933. Registered on March 2018.

scholarly journals Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: A double blind, sham controlled, randomized clinical trial

2019 ◽  
Author(s):  
Clara Sanches ◽  
Richard Levy ◽  
Sarah Benisty ◽  
Lisette Volpe-Gillot ◽  
Marie-Odile Habert ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Semantic Dementia ◽  
Therapeutic Effects ◽  
Double Blind ◽  
Temporal Lobes ◽  
Time Points ◽  
Direct Current Stimulation ◽  
Cathodal Tdcs

Abstract Background Semantic dementia is a neurodegenerative disease that primarily affects the left anterior temporal lobe, resulting in a gradual loss of conceptual knowledge. There is currently no validated treatment. Transcranial stimulation has provided evidence for long-lasting language effects presumably linked to stimulation-induced neuroplasticity in post-stroke aphasia. However, studies evaluating its effects in neurodegenerative diseases as semantic dementia are still rare and evidence from double blind prospective therapeutic trials is required. Objective The primary objective of the present clinical trial (STIM-SD) is to evaluate the therapeutic efficacy of a multiday transcranial direct current stimulation (tDCS) regime on language impairment in patients with semantic dementia. The study also explores the time course of potential tDCS-driven improvements and uses imaging biomarkers which could reflect stimulation-induced neuroplasticity. Methods Double-blind sham-controlled randomized study using tDCS applied daily during 10 days, and language/semantic and imaging assessments at 4 time-points: baseline, 3 days, 2 weeks and 4 months after the 10 stimulation sessions. Language/semantic assessments will be applied at the 4 time-points. Fluorodeoxyglucose Positron Emission tomography (FDG-PET), resting-state functional Magnetic Resonance Imaging (rs-fMRI), T1-weighted images and white matter diffusion tensor imaging (DTI) will be applied at baseline and the two-weeks’ time-point. According to the principle of inter-hemispheric inhibition between left (language-related) and right homotopic regions we will use two stimulation modalities: left-anodal and right-cathodal tDCS over the anterior temporal lobes. Accordingly, the patient population (n=60) will be subdivided into 3 subgroups: left-anodal tDCS (n=20), right-cathodal tDCS (n=20) and sham tDCS (n=20). The stimulation duration will be sustained for 20 minutes at an intensity of 1.59 mA. It will be delivered through 25cm2 round stimulation electrodes (current density of 0.06 mA/cm2) placed over the left and right anterior temporal lobes for anodal and cathodal stimulation, respectively. A group of age, gender and education-matched healthy participants (n=20) will also be recruited and tested to provide normative values for the language/semantic tasks and imaging measures. Discussion The study aims at assessing the efficacy of tDCS for language/semantic disorders in semantic dementia. A potential treatment would be easily applicable, inexpensive, and renewable when therapeutic effects disappear due to disease progression.

scholarly journals Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: A double blind, sham controlled, randomized clinical trial (Preprint)

2019 ◽  
Author(s):  
Clara Sanches ◽  
Richard Levy ◽  
Sarah Benisty ◽  
Lisette Volpe-Gillot ◽  
Marie-Odile Habert ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Semantic Dementia ◽  
Therapeutic Effects ◽  
Base Line ◽  
Double Blind ◽  
Temporal Lobes ◽  
Time Points ◽  
Cathodal Tdcs

BACKGROUND Semantic dementia is a neurodegenerative disease that primarily affects the left anterior temporal lobe. It results in a gradual loss of conceptual knowledge resulting in anomia and impaired word comprehension which severely impact on communications abilities. There is currently no validated treatment. Transcranial stimulation has provided evidence for long-lasting language effects presumably linked to stimulation-induced neuroplasticity in post-stroke aphasia. However, studies evaluating its effects in neurodegenerative diseases as semantic dementia are still rare and evidence from double blind prospective therapeutic trials is required. OBJECTIVE The primary objective of the present clinical trial (STIM-SD) is to evaluate the therapeutic efficacy of a multiday transcranial direct current stimulation (tDCS) regime on language/semantic impairment in patients with semantic dementia. The study also explores the time course of potential tDCS-driven improvements and uses imaging biomarkers which could reflect stimulation-induced neuroplasticity. METHODS Double-blind sham-controlled randomized study using tDCS which will be applied daily during 10 days, and language/semantic and imaging assessments at 4 time-points: base-line, 3 days, 2 weeks and 4 months after the 10 stimulation sessions. Language/semantic assessments will be applied at the 4 time-points. Fluorodeoxyglucose Positron Emission tomography (FDG-PET), resting-state functional Magnetic Resonance Imaging (rs-fMRI), T1-weighted images for cortical thickness measures and white matter diffusion tensor imaging (DTI) will be applied at base-line and the two-weeks’ time-point. According to the principle of inter-hemispheric inhibition between left (language-related) and right homotopic regions we will use two potentially efficient stimulation modalities: left-anodal and right-cathodal tDCS over the anterior temporal lobes. This approach allows for comparing two stimulation strategies and aims at revealing the most beneficial strategy. Accordingly, the patient population (n=60) will be subdivided into 3 subgroups: left-anodal tDCS (n=20), right-cathodal tDCS (n=20) and sham tDCS (n=20). The stimulation duration will be sustained for 20 minutes at an intensity of 1.59 mA. It will be delivered through 25cm2 round stimulation electrodes (current density of 0.06 mA/cm2) placed over the left and right anterior temporal lobes for anodal and cathodal stimulation, respectively. A group of age, gender and education-matched healthy participants (n=20) will also be recruited and tested to provide normative values for the language/semantic tasks and imaging measures. RESULTS Ten patients have been screened for participation between June 2018 and December 2018, and 7 patients have been included in the study and randomized. Three patients have already completed the 4-month follow-up. Data analysis will begin once all study data are collected. CONCLUSIONS The study aims at assessing the efficacy of tDCS as a new therapeutic approach for language/semantic disorders in semantic dementia. A potential treatment would be easily applicable, inexpensive, and renewable when therapeutic effects disappear due to disease progression. CLINICALTRIAL ClinicalTrials.gov NCT03481933

scholarly journals Cathodal Transcranial Direct Current Stimulation of the Occipital cortex in Episodic Migraine: A Randomized Sham-Controlled Crossover Study

2019 ◽  
Vol 9 (1) ◽  
pp. 60 ◽  
Author(s):  
Rechdi Ahdab ◽  
Anthony G. Mansour ◽  
Georges Khazen ◽  
Christelle El-Khoury ◽  
Toni M. Sabbouh ◽  
...  
Keyword(s):  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Controlled Trial ◽  
Occipital Cortex ◽  
Episodic Migraine ◽  
Migraine Prophylaxis ◽  
Double Blind ◽  
Direct Current Stimulation ◽  
Beneficial Effects ◽  
Cathodal Tdcs

Summary: Three consecutive daily sessions of cathodal transcranial direct current stimulation (tDCS) was sufficient to show a significant decrease in headache duration and intensity as well as tablets consumption, in patients suffering from episodic migraine. Background: Migraine prophylaxis is recommended in patients with frequent and/or intense headaches, but poor tolerability and lack of efficacy of preventive drugs are common in clinical practice. Hence, new prophylactic strategies are needed. Objective: The aim of this study was to evaluate the efficacy of tDCS in terms of migraine prophylaxis. Methods: This was a double blind and sham-controlled trial. Forty-two migraine patients were randomly assigned in a crossover design to receive three consecutive daily sessions of both sham and cathodal tDCS stimulation (2.0 mA, 20 min) over the occipital cortex of the dominant side of the migraine pain (O1/O2). Migraine duration and intensity, number of analgesic tablets, and number of headache-free days (where no headache abortive medications are taken) were recorded one week before and two weeks after treatment. A washout period of one week was allowed before crossing to the other treatment arm. Results: Relative to sham, cathodal stimulation was associated with a significant reduction in the number of headache days, tablets consumption, and pain intensity; and a significant increase in the number of headache-free days. These beneficial effects were sustained over two weeks. No serious side effects were observed, and the procedure was well tolerated. Conclusion: Based on these findings, cathodal tDCS applied to the occipital cortex seems to be an effective and well tolerated alternative to pharmacotherapy in patients with episodic migraine.

scholarly journals Optimised transcranial direct current stimulation (tDCS) for fibromyalgia—targeting the endogenous pain control system: a randomised, double-blind, factorial clinical trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e032710 ◽  
Author(s):  
Luis Castelo-Branco ◽  
Elif Uygur Kucukseymen ◽  
Dante Duarte ◽  
Mirret M El-Hagrassy ◽  
Camila Bonin Pinto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Control System ◽  
Aerobic Exercise ◽  
Clinical Outcomes ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Pain Control ◽  
Pain Modulation ◽  
Double Blind ◽  
Direct Current Stimulation

IntroductionFibromyalgia (FM) is a common debilitating condition with limited therapeutic options. Medications have low efficacy and are often associated with adverse effects. Given that FM is associated with a defective endogenous pain control system and central sensitisation, combining interventions such as transcranial direct current stimulation (tDCS) and aerobic exercise (AE) to modulate pain-processing circuits may enhance pain control.Methods and analysisA prospective, randomised (1:1:1:1), placebo-controlled, double-blind, factorial clinical trial will test the hypothesis that optimised tDCS (16 anodal tDCS sessions combined with AE) can restore of the pain endogenous control system. Participants with FM (n=148) will undergo a conditioning exercise period and be randomly allocated to one of four groups: (1) active tDCS and AE, (2) sham tDCS and AE, (3) active tDCS and non-aerobic exercise (nAE) or (4) sham tDCS and nAE. Pain inhibitory activity will be assessed using conditioned pain modulation (CPM) and temporal slow pain summation (TSPS)—primary outcomes. Secondary outcomes will include the following assessments: Transcranial magnetic stimulation and electroencephalography as cortical markers of pain inhibitory control and thalamocortical circuits; secondary clinical outcomes on pain, FM, quality of life, sleep and depression. Finally, the relationship between the two main mechanistic targets in this study—CPM and TSPS—and changes in secondary clinical outcomes will be tested. The change in the primary efficacy endpoint, CPM and TSPS, from baseline to week 4 of stimulation will be tested with a mixed linear model and adjusted for important demographic variables.Ethics and disseminationThis study obeys the Declaration of Helsinki and was approved by the Institutional Review Board (IRB) of Partners Healthcare under the protocol number 2017P002524. Informed consent will be obtained from participants. Study findings will be reported in conferences and peer-reviewed journal publications.Trial registration numberNCT03371225.

scholarly journals Effects of transcranial direct current stimulation on patients with post stroke fatigue: A study protocol for a double-blind randomized controlled trial

2021 ◽  
Author(s):  
Weiming Sun ◽  
Xing Sun ◽  
Xiangli Dong ◽  
Guohua Yu ◽  
Lang Shuai ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Controlled Trial ◽  
Double Blind ◽  
Direct Current Stimulation ◽  
Post Stroke ◽  
Randomized Controlled

Abstract Introduction Post stroke fatigue (PSF) is an abnormal, persistent, and unexplained physical and psychological tiredness in patients after stroke. It is a common symptom of stroke patients with poor quality of life and bleak prognosis, and the incidence rate is up to 39–72%. It has been widely reported that medicine treatments achieved a lot of progress, there still needs to develop more powerful new strategies to more powerful effect. The transcranial direct-current stimulation (tDCS) shows great potential for the treatment of PSF. This study proposes to apply a double-blind randomized controlled clinical trial to explore the effect and safety of tDCS combined with routine rehabilitation for PSF. Methods and analysis One hundred patients with PSF will be randomly divided into two groups. One of the groups will receive conventional rehabilitation therapy and active tDCS, whereas another group will receive conventional rehabilitation treatment and sham tDCS. Both groups will receive the intervention for 4 weeks, during which time they will undergo either active or sham tDCS 20 minutes a day, 6 days a week. Primary outcome: Fatigue Severity Scale (FSS) will be measured at baseline every weekend during the intervention period. Secondary results: Fatigue Impact Scale (FIS), Functional Assessment Chronic Illness Therapy (Fatigue) (FACIT-F), Specialized Quality of Life Scale in Stroke (SS-QOL) will be measured at baseline and at the end of the intervention time of 4 weeks. Throughout the study, adverse events and adverse reactions will be measured during every treatment. The research study”Effects of transcranial direct current stimulation on patients with post stroke fatigue” has been approved by the Ethics Committee of the First Affiliated Hospital of Nanchang University: Clinical Medicine Ethics Review [2015]043 in Nov, 2015. Discussion This study will provide insight on the efficacy of transcranial direct-current stimulation for post stroke fatigue. This is a double-blind randomized controlled trial whose aim is to assess the effects of tDCS on PSF.This study can provide more information about the treatment of PSF. This study has a period of follow-up, which allows for greater accuracy. It is a single-center trial and this may be a limitation. The other limitation of this study is a relatively small number of participants; thus, the influence of chance on experimental results cannot be completely ruled out. Trial registration number Chinese Clinical Trial Registry,ChiCTR2000031120. Registered on March 22, 2020. This protocol version number is V1.1.

scholarly journals Repeated sessions of bilateral transcranial direct current stimulation on intractable tinnitus: a study protocol for a double-blind randomized controlled trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 317 ◽  
Author(s):  
Arash Bayat ◽  
Miguel Mayo ◽  
Samaneh Rashidi ◽  
Nader Saki ◽  
Ali Yadollahpour
Keyword(s):  
Clinical Trial ◽  
Treatment Response ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Controlled Trial ◽  
Chronic Tinnitus ◽  
Post Intervention ◽  
Double Blind ◽  
Direct Current Stimulation

Background: Transcranial Direct Current Stimulation (tDCS) is reportedly a potential treatment option for chronic tinnitus. The main drawbacks of previous studies are short term follow up and focusing on the efficacy of single session tDCS. This study aims to investigate the therapeutic efficacy, adverse effects (AEs) and tolerability of repeated sessions of bilateral tDCS over auditory cortex (AC) on tinnitus symptoms Methods: This will be a double-blinded randomized placebo controlled parallel trial on patients (n=90) with intractable chronic tinnitus (> 2 years) randomly divided into three groups of anodal, cathodal, and sham tDCS. In the sham treatment, after 30 sec the device will be turned OFF without informing the patients. The tDCS protocol consists of 10 sessions (daily  20 min session; 2 mA current for 5 consecutive days per week and 2 consecutive weeks) applied through 35 cm2 electrodes. The primary outcome is tinnitus handicap inventory (THI) which will be assessed pre- and post-intervention and at one month follow-up. The secondary outcomes are tinnitus loudness and distress to be assessed using a visual analogue scale (VAS) pre-intervention, and immediately, one hour, one week, and one month after last stimulation. The AEs and tolerability of patients will be evaluated after each session using a customized questionnaire. Possible interactions between the disease features and treatment response will be evaluated.   Discussion: To our knowledge this is the first study to investigate the effects of repeated sessions of tDCS on chronic tinnitus symptoms with one month follow-up. In addition, the AEs, and tolerability of patients will be studied. In addition, the possible interactions between the disease specific features including the hearing loss, laterality, type of tinnitus, and treatment response will be evaluated.   Trial registration: The study has been registered as a clinical trial in Iranian Registry of Clinical Trial (IRCT2016110124635N6) on the 01/06/2017.

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