NCT02769312

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 5, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

April 29, 2016

Results QC Date

February 12, 2019

Last Update Submit

March 14, 2019

Conditions

Chronic Post-Traumatic Stress Disorder

Keywords

Quality of LifePost-Traumatic Stress DisorderTranscranial Magnetic StimulationFeasibility studies

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Retained, a Measure of Acceptability of TBS Procedures

    Measurement of TBS acceptability, measured using participant retention rates (all-cause discontinuation)

    2 weeks

Secondary Outcomes (3)

  • Change in Quality of Life Due to TBS Treatment

    Baseline and end of double-blind period (2 weeks)

  • Change in PTSD Symptom Severity

    Baseline and end of double-blind period (2 weeks)

  • Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment

    Baseline and end of double-blind period (2 weeks)

Study Arms (2)

Sham Stimulation

SHAM COMPARATOR

A sham coil is being used to compare against active coil.

Device: Sham stimulation

Active Stimulation

ACTIVE COMPARATOR

An active coil is being used to compare against sham coil.

Device: Theta burst stimulation

Interventions

Theta burst stimulationDEVICE

Theta burst transcranial magnetic stimulation

Active Stimulation
Sham stimulationDEVICE

Sham Theta burst transcranial magnetic stimulation

Sham Stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

Related Publications (1)

  • Philip NS, Barredo J, Aiken E, Larson V, Jones RN, Shea MT, Greenberg BD, van 't Wout-Frank M. Theta-Burst Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder. Am J Psychiatry. 2019 Nov 1;176(11):939-948. doi: 10.1176/appi.ajp.2019.18101160. Epub 2019 Jun 24.

    PMID: 31230462DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Dr. Noah S. Philip
Organization
Providence VA Medical Center, Center for Neurorestoration and Neurotechnology
noah.philip@va.gov
401-273-7100

Study Officials

  • Noah S. Philip, MD

    Providence VA Medical Center, Providence, RI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 11, 2016

Study Start

April 1, 2016

Primary Completion

December 19, 2017

Study Completion

December 19, 2017

Last Updated

March 26, 2019

Results First Posted

March 5, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)