Theta-Burst Neuromodulation for PTSD

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Chronic Post-Traumatic Stress Disorder

In brief

The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment for Veterans with PTSD. Primary outcomes measures include a feasibility of TBS procedures, with secondary outcome measures focusing on changes in PTSD symptom severity and quality of life and social/occupation functioning.

Key facts

Study ID

NCT02769312

Run by

VA Office of Research and Development

People needed

56

Starts

2016-04-01

Expected to finish

2017-12-19

Last updated by the study team

2019-03-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chronic PTSD according to DSM-5 criteria
• Veteran (male or female)
• age between 18-70 years
• clinically symptomatic despite ongoing stable treatment regimens for at least 6 weeks prior to study procedures
• capable of independently reading and understanding patient information materials and providing informed consent

You may not qualify if…

• Cardiac pacemaker
• implanted device (deep brain stimulation) or metal in the brain
• cervical spinal cord
• or upper thoracic spinal cord
• pregnancy/lactation, or planning to become pregnant during the study
• lifetime history of moderate or severe traumatic brain injury (TBI)
• current unstable medical conditions
• current (or past if appropriate) significant neurological disorder, or lifetime history of:
• seizure disorder
• primary or secondary CNS tumors
• stroke
• cerebral aneurysm
• primary psychotic disorder
• bipolar I disorder
• active moderate/severe substance use disorders (within the last month, excluding nicotine/caffeine
• active suicidal intent or plan

Where it is running

• Providence VA Medical Center, Providence, RI — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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