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Theta-Burst Neuromodulation for PTSD

NCT02769312 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-03-26

Study results available
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Summary

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.

Conditions

  • Chronic Post-Traumatic Stress Disorder

Interventions

DEVICE

Theta burst stimulation

Theta burst transcranial magnetic stimulation

DEVICE

Sham stimulation

Sham Theta burst transcranial magnetic stimulation

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Noah S. Philip, MD · Providence VA Medical Center, Providence, RI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2017-12-19
Completion
2017-12-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02769312 on ClinicalTrials.gov