Chronic Post-Traumatic Stress DisorderPhase 1/2TBSNCT02769312
Theta-Burst Neuromodulation for PTSD
A Phase 1/2 study testing Theta burst stimulation in people with Chronic Post-Traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Post-Traumatic Stress Disorder
- What is being tested?
- Theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 19 Dec 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908
About this study
Official title: Pilot Testing of Theta-Burst Neuromodulation for Chronic PTSD
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.
Read the detailed description
The purpose of the proposed study is to evaluate the feasibility of theta burst transcranial magnetic stimulation (TBS) as an adjunct treatment for Veterans with PTSD. This project will result in development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD, which will assess the relationship between change in symptoms and quality of life. It will also lay the foundation for subsequent rehabilitation studies combining neuromodulation and psychotherapy in the longer term.
TBS has several advantages compared to standard repetitive Transcranial Magnetic Stimulation (rTMS), including its ability to deliver large numbers of stimulation pulses in a shorter time period, and a stimulation pattern that may specifically affect key brain regions involved in PTSD. The significance of this research is the development of a novel, non-invasive brain stimulation approach for PTSD recovery. This project will provide the foundation for the development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD to ultimately develop brain stimulation techniques that can be combined with evidence-based psychotherapy, to develop a more powerful, individualized rehabilitation option for Veterans with PTSD.
- Conditions
- Chronic Post-Traumatic Stress Disorder
- Being tested
- Theta burst stimulation, Sham stimulation
- Keywords
- Quality of Life, Post-Traumatic Stress Disorder, Transcranial Magnetic Stimulation, Feasibility studies
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta burst stimulationDevice
Theta burst transcranial magnetic stimulation
Sham stimulationDevice
Sham Theta burst transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| Sham Stimulation | Sham comparator | A sham coil is being used to compare against active coil. Receives: Device: Sham stimulation |
| Active Stimulation | Active comparator | An active coil is being used to compare against sham coil. Receives: Device: Theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Retained, a Measure of Acceptability of TBS Procedures
Measurement of TBS acceptability, measured using participant retention rates (all-cause discontinuation)
Measured: 2 weeks
Secondary outcomes (3)
Change in Quality of Life Due to TBS Treatment
Change in the quality of life, using the quality of life questionnaire QLESQ - Quality of Life Enjoyment and Satisfaction Questionnaire (General Quality of Life Index).
A self-report scale covering multiple domains (physical health, subjective feelings, leisure time activities, social relationships, treatment satisfaction) The General Quality of Life Index took the mean of all domains. Scores range from 0-5, with higher scores indicating higher quality of life.
Measured: Baseline and end of double-blind period (2 weeks)
Change in PTSD Symptom Severity
Change in PTSD symptoms measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
The CAPS-5 is a structured interview to measure for PTSD symptom change and presence/absence of PTSD, items rated 0 = 'absent' to 4 = 'extreme/incapacitating,' total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Higher scores indicate more severe PTSD symptoms.
Measured: Baseline and end of double-blind period (2 weeks)
Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment
Change measured using the social/occupational functioning assessment scale (SOFAS).
Clinician rating of social \& occupational functioning. Scale of 0-100 with higher scores indicating higher functioning.
Measured: Baseline and end of double-blind period (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start1 Apr 2016
- Primary completion19 Dec 2017
- Study completion19 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Noah S. Philip, MD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769312
- Sponsor's protocol ID
- D2032-P
- Other IDs
- I21RX RX002032
- Acronym
- TBS
- Status last verified
- Mar 2019
- First submitted
- 29 Apr 2016
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31230462
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing of Theta-Burst Neuromodulation for Chronic PTSD
- ClinicalTrials.gov ID
- NCT02769312
- Acronym / sponsor ID
- TBS / D2032-P
- Conditions
- Chronic Post-Traumatic Stress Disorder
- Keywords
- Quality of Life, Post-Traumatic Stress Disorder, Transcranial Magnetic Stimulation, Feasibility studies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the proposed study is to evaluate the feasibility of theta burst transcranial magnetic stimulation (TBS) as an adjunct treatment for Veterans with PTSD. This project will result in development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD, which will assess the relationship between change in symptoms and quality of life. It will also lay the foundation for subsequent rehabilitation studies combining neuromodulation and psychotherapy in the longer term.
TBS has several advantages compared to standard repetitive Transcranial Magnetic Stimulation (rTMS), including its ability to deliver large numbers of stimulation pulses in a shorter time period, and a stimulation pattern that may specifically affect key brain regions involved in PTSD. The significance of this research is the development of a novel, non-invasive brain stimulation approach for PTSD recovery. This project will provide the foundation for the development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD to ultimately develop brain stimulation techniques that can be combined with evidence-based psychotherapy, to develop a more powerful, individualized rehabilitation option for Veterans with PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Stimulation | Sham comparator | Device: Sham stimulationA sham coil is being used to compare against active coil. |
| Active Stimulation | Active comparator | Device: Theta burst stimulationAn active coil is being used to compare against sham coil. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theta burst stimulationTheta burst transcranial magnetic stimulation | Device | Active Stimulation |
| Sham stimulationSham Theta burst transcranial magnetic stimulation | Device | Sham Stimulation |
Primary outcome
Number of Participants Retained, a Measure of Acceptability of TBS Procedures
Time frame: 2 weeks
Measurement of TBS acceptability, measured using participant retention rates (all-cause discontinuation)
3 secondary outcomes
Change in Quality of Life Due to TBS Treatment
Time frame: Baseline and end of double-blind period (2 weeks)
Change in PTSD Symptom Severity
Time frame: Baseline and end of double-blind period (2 weeks)
Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment
Time frame: Baseline and end of double-blind period (2 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31230462Philip 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah S. Philip, MD principal investigator
Providence VA Medical Center, Providence, RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Theta burst stimulation in people with Chronic Post-Traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Retained, a Measure of Acceptability of TBS Procedures (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02769312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.