135 Evolution of a Study of Bilateral Prefrontal Transcranial Magnetic Stimulation (TMS) to Treat the Symptoms of Mild TBI (mTBI) and PTSD

Disclaimer:The views expressed in this abstract are those of the authors and do not reflect the official policy of the Department of Army/Navy/Air Force, Department of Defense, or U.S. Government.Background:Traumatic brain injuries (TBIs) have affected nearly 380,000 service members since 2000. Comorbid posttraumatic stress disorder (PTSD) may result from and/or exacerbate sequelae of mild TBI (mTBI) and is suspected to affect up to 65% of service members with TBI. Conventional treatments for mTBI/PTSD symptoms have limited efficacy and are associated with undesirable side effects. Repetitive transcranial magnetic stimulation (rTMS) has shown promise in treating PTSD symptoms and been identified as a potential mTBI therapy, but is untested as a therapy for comorbid mTBI/PTSD.Methods:This double-blinded, prospective randomized, sham-controlled study consists of 30 treatment sessions 5 weeks of daily sessions followed by a two week taper of 3 and 2 sessions, respectively. Sessions consist of 3500 pulses administered to the left dorsolateral prefrontal cortex (dlPFC) at 10 Hz and 1500 pulses to the right dlPFC at 1 Hz. Approximately 60-80 participants will be randomized to receive active or sham rTMS. Primary outcome measures are the Posttraumatic Checklist 5 and the Rivermead Post-Concussion Questionnaire.Results:The study is ongoing, and 26 participants have been recruited to date. All patients were formally diagnosed with mTBI and reported moderate to severe PTSD symptoms. Preliminary data show no participants have withdrawn due to intolerability or indicated intolerability, despite the presence of minor discomforts such as headache. The majority of participants have been able to rest quietly or sleep during sessions, indicating high tolerability. Reported pain levels are low, with average ratings of 2.84/10.00 by week 2. One limitation was a high dropout rate.Conclusions:This study aims to provide guidance as to whether rTMS is an efficacious therapy for comorbid mTBI/PTSD. Preliminary data indicates it to be a tolerable and safe therapy. Future research should consider decreasing the demand of the study on patients schedules, and performing a comparison to other mTBI/PTSD treatments to determine what treatment is more efficacious.

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A randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving

PLoS ONE ◽

10.1371/journal.pone.0259860 ◽

2021 ◽

Vol 16 (11) ◽

pp. e0259860

Author(s):

Francesco Lolli ◽

Maya Salimova ◽

Maenia Scarpino ◽

Giovanni Lanzo ◽

Cesarina Cossu ◽

...

Keyword(s):

Prefrontal Cortex ◽

Transcranial Magnetic Stimulation ◽

Magnetic Stimulation ◽

Repetitive Transcranial Magnetic Stimulation ◽

Survival Curve ◽

Dropout Rate ◽

Treated Group ◽

Controlled Study ◽

Double Blind ◽

Cocaine Use

Background Cocaine use disorder (CUD) is a global health issue with no effective treatment. Repetitive Transcranial Magnetic Stimulation (rTMS) is a recently proposed therapy for CUD. Methods We conducted a single-center, randomised, sham-controlled, blinded, parallel-group research with patients randomly allocated to rTMS (15 Hz) or Sham group (1:1) using a computerised block randomisation process. We enrolled 62 of 81 CUD patients in two years. Patients were followed for eight weeks after receiving 15 15 Hz rTMS/sham sessions over the left dorsolateral prefrontal cortex (DLPFC) during the first three weeks of the study. We targeted the DLFPC following the 5 cm method. Cocaine lapses in twice a week urine tests were the primary outcome. The secondary outcomes were craving severity, cocaine use pattern, and psychometric assessments. Findings We randomly allocated patients to either an active rTMS group (32 subjects) or a sham treatment group (30 subjects). Thirteen (42%) and twelve (43.3%) of the subjects in rTMS and sham groups, respectively, completed the full trial regimen, displaying a high dropout rate. Ten/30 (33%) of rTMS-treated patients tested negative for cocaine in urine, in contrast to 4/27 of placebo controls (p = 0.18, odd ratio 2.88, CI 0.9–10). The Kaplan-Meier survival curve did not state a significant change between the treated and sham groups in the time of cocaine urine negativisation (p = 0.20). However, the severity of cocaine-related cues mediated craving (VAS peak) was substantially decreased in the rTMS treated group (p<0.03) after treatment at T1, corresponding to the end of rTMS treatment. Furthermore, in the rTMS and sham groups, self-reported days of cocaine use decreased significantly (p<0.03). Finally, psychometric impulsivity parameters improved in rTMS-treated patients, while depression scales improved in both groups. Conclusions In CUD, rTMS could be a useful tool for lowering cocaine craving and consumption. Trial registration The study number on clinicalTrials.gov is NCT03607591.

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