Posttraumatic Stress Disorder (PTSD)Early Phase 1NCT02442843
Non Invasive Brain Stimulation for PTSD
A Early Phase 1 study testing Active tDCS in people with Posttraumatic Stress Disorder (PTSD), run by University of Michigan at 1 site in United States.
Trial summary
This study is designed to identify changes in the brain that underlie symptoms of combat-related PTSD using brain imaging (fMRI). Then, the investigators will administer mild electrical stimulation to the side of the head (using a method called tDCS) in an attempt to reduce the symptoms of PTSD. Read more about this study
- Who is it for?
- Ages 18 to 88 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 1 Aug 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 88 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Combat Veteran - both Veterans with and without PTSD will be included at different points in this study
- Right-handed
- Between the ages 18-88
- Stable on medications for a minimum of 2 weeks
Who cannot join
- a history of neurological disease (e.g., dementia, epilepsy, stroke, moderate - severe traumatic brain injury)
- "severe" Axis I diagnoses (e.g., bipolar disorder, schizophrenia)
- presence of Axis II disorders
- current alcohol or drug abuse/dependence (in the past 8 weeks)
- participants will also be excluded if they are not MRI compatible (assessed using the guidelines of the American College of Radiology)
- Imminent risk of harm to self or others
- history of HIV or sickle cell anemia, as these can cause neuropsychological issues .
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Neuropsychology Section
Ann Arbor, Michigan, 48105
About this study
Official title: Non-invasive Brain Stimulation for Post-Traumatic Stress Disorder
This study is designed to identify changes in the brain that underlie symptoms of combat-related PTSD using brain imaging (fMRI). Then, the investigators will administer mild electrical stimulation to the side of the head (using a method called tDCS) in an attempt to reduce the symptoms of PTSD.
Read the detailed description
Being involved in combat is a horrific experience that substantially increases the risk of developing posttraumatic stress disorder (PTSD). Although several effective treatments have been identified for PTSD a substantial number of patients (up to 50%) continue to experience symptoms. The field of neuroscience has revealed that patients with PTSD demonstrate altered functioning within, and interactions between, several brain regions; findings that are consistent with animal models of chronic stress. Despite this evidence, existing treatments are generally not designed using this neuroanatomical knowledge. The central premise of the proposed study is that neuroscientifically-based information can be used to develop more precise and effective treatments. Transcranial direct current stimulation (tDCS) will be used in an attempt to "correct" the dysfunctional brain regions (and communication between these regions), with the expectation that this modulation will result in symptom improvement.
The primary goals of the study are to verify the maladaptive brain networks and then establish evidence that tDCS modulates these networks. Subsequent studies, performed during the later study years, will examine dose-response relationships and synergistic effects of tDCS and existing treatments. Outcome will be assessed using a multi-method approach that includes functional connectivity using resting-state functional magnetic resonance imaging data, neuropsychological tests, and self-report measures of emotional functioning. The combined results will provide vital methodological, mechanistic, and practical information necessary for a formal clinical trial of tDCS in PTSD.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Active tDCS, Sham tDCS
- 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.
Active tDCSDevice
Also called mild brain stimulation, HD-tDCS
Participants will be randomized into active or sham stimulation in the first tDCS session. Participants will then have the option to complete 9 additional session of tDCS which will be active tDCS or a combination of active and sham tDCS in a non-randomized manner over two consecutive weeks. Each session will last 1 - 2 hours.
Sham tDCSDevice
Also called fake tDCS
Participants will be randomized into active or sham stimulation in the first tDCS session. Participants will then have the option to complete 9 additional session of tDCS which will be active tDCS or a combination of active and sham tDCS in a non-randomized manner over two consecutive weeks. Each session will last 1 - 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Experimental | Investigators will use cathodal tDCS to inhibit the brain regions that may be associated with symptoms of PTSD (temporal cortex). Active tDCS will be provided at 2 miliamps (mA) for 20 minutes (with gradual increase and withdraw of stimulation during the first and last minute). Receives: Device: Active tDCS |
| sham tDCS | Sham comparator | Participants randomized to the sham condition will receive stimulation during the first and final minutes of the 20 minute period (with gradual increase and removal of current during that time). Receives: Device: Sham tDCS |
| Combat Controls | No intervention | Participants without PTSD will undergo neuropsychological testing and a single fMRI scan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Connectivity changes as assessed by fMRI images
Investigators will use the fMRI images taken from before and after tDCS to determine if the treatment intervention contributed to any changes within the neural networks associated with the symptoms of PTSD.
Measured: Pre and post tDCS; typically within 4 weeks
Secondary outcomes (8)
Symptomatic changes as assessed by structured questionnaires (PCL-C)
PTSD checklist
Measured: Pre and post tDCS; typically within 4 weeks
Symptomatic changes as assessed by structured questionnaires (CAPS)
Clinician administered PTSD Scale
Measured: Pre and post tDCS; typically within 4 weeks
Symptomatic changes as assessed by structured questionnaires (Hamilton Depression Rating Scale)
Current symptoms of depression
Measured: Pre and post tDCS; typically within 4 weeks
Symptomatic changes as assessed by structured questionnaires (State-trait anxiety inventory)
current symptoms of anxiety
Measured: Pre and post tDCS; typically within 4 weeks
Cognitive changes as assessed by Neuropsychological testing
Verbal (HVLT) and visuospatial memory (object-location association test)
Measured: Pre and post tDCS; typically within 4 weeks
Cognitive changes as assessed by Neuropsychological testing
Working memory (n-back)
Measured: Pre and post tDCS; typically within 4 weeks
Cognitive changes as assessed by Neuropsychological testing
inhibitory control (go/no-go; flanker task; pattern comparison task)
Measured: Pre and post tDCS; typically within 4 weeks
Cognitive changes as assessed by Neuropsychological testing
Executive functioning (Dimensional change card sort)
Measured: Pre and post tDCS; typically within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startMay 2015
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Benjamin Hampstead, PhD, University of Michigan
- Investigators
- Benjamin Hampstead, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442843
- Sponsor's protocol ID
- HUM00089481
- Other IDs
- 1R21MH102539-01
- Status last verified
- Aug 2018
- First submitted
- 17 Feb 2015
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Brain Stimulation for Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02442843
- Acronym / sponsor ID
- HUM00089481
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2015 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to identify changes in the brain that underlie symptoms of combat-related PTSD using brain imaging (fMRI). Then, the investigators will administer mild electrical stimulation to the side of the head (using a method called tDCS) in an attempt to reduce the symptoms of PTSD.
Detailed description
Being involved in combat is a horrific experience that substantially increases the risk of developing posttraumatic stress disorder (PTSD). Although several effective treatments have been identified for PTSD a substantial number of patients (up to 50%) continue to experience symptoms. The field of neuroscience has revealed that patients with PTSD demonstrate altered functioning within, and interactions between, several brain regions; findings that are consistent with animal models of chronic stress. Despite this evidence, existing treatments are generally not designed using this neuroanatomical knowledge. The central premise of the proposed study is that neuroscientifically-based information can be used to develop more precise and effective treatments. Transcranial direct current stimulation (tDCS) will be used in an attempt to "correct" the dysfunctional brain regions (and communication between these regions), with the expectation that this modulation will result in symptom improvement.
The primary goals of the study are to verify the maladaptive brain networks and then establish evidence that tDCS modulates these networks. Subsequent studies, performed during the later study years, will examine dose-response relationships and synergistic effects of tDCS and existing treatments. Outcome will be assessed using a multi-method approach that includes functional connectivity using resting-state functional magnetic resonance imaging data, neuropsychological tests, and self-report measures of emotional functioning. The combined results will provide vital methodological, mechanistic, and practical information necessary for a formal clinical trial of tDCS in PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Experimental | Device: Active tDCSInvestigators will use cathodal tDCS to inhibit the brain regions that may be associated with symptoms of PTSD (temporal cortex). Active tDCS will be provided at 2 miliamps (mA) for 20 minutes (with gradual increase and withdraw of stimulation during the first and last minute). |
| sham tDCS | Sham comparator | Device: Sham tDCSParticipants randomized to the sham condition will receive stimulation during the first and final minutes of the 20 minute period (with gradual increase and removal of current during that time). |
| Combat Controls | No intervention | –Participants without PTSD will undergo neuropsychological testing and a single fMRI scan. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- Combat Veteran - both Veterans with and without PTSD will be included at different points in this study
- Right-handed
- Between the ages 18-88
- Stable on medications for a minimum of 2 weeks
Key exclusion criteria (7 listed)
- a history of neurological disease (e.g., dementia, epilepsy, stroke, moderate - severe traumatic brain injury)
- "severe" Axis I diagnoses (e.g., bipolar disorder, schizophrenia)
- presence of Axis II disorders
- current alcohol or drug abuse/dependence (in the past 8 weeks)
- participants will also be excluded if they are not MRI compatible (assessed using the guidelines of the American College of Radiology)
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 |
|---|---|---|
| Active tDCSAlso: mild brain stimulation, HD-tDCSParticipants will be randomized into active or sham stimulation in the first tDCS session. Participants will then have the option to complete 9 additional session of tDCS which will be active tDCS or a combination of active and sham tDCS in a non-randomized manner over two consecutive weeks. Each session will last 1 - 2 hours. | Device | active tDCS |
| Sham tDCSAlso: fake tDCSParticipants will be randomized into active or sham stimulation in the first tDCS session. Participants will then have the option to complete 9 additional session of tDCS which will be active tDCS or a combination of active and sham tDCS in a non-randomized manner over two consecutive weeks. Each session will last 1 - 2 hours. | Device | sham tDCS |
Primary outcome
Functional Connectivity changes as assessed by fMRI images
Time frame: Pre and post tDCS; typically within 4 weeks
Investigators will use the fMRI images taken from before and after tDCS to determine if the treatment intervention contributed to any changes within the neural networks associated with the symptoms of PTSD.
8 secondary outcomes
Symptomatic changes as assessed by structured questionnaires (PCL-C)
Time frame: Pre and post tDCS; typically within 4 weeks
Symptomatic changes as assessed by structured questionnaires (CAPS)
Time frame: Pre and post tDCS; typically within 4 weeks
Symptomatic changes as assessed by structured questionnaires (Hamilton Depression Rating Scale)
Time frame: Pre and post tDCS; typically within 4 weeks
Symptomatic changes as assessed by structured questionnaires (State-trait anxiety inventory)
Time frame: Pre and post tDCS; typically within 4 weeks
Cognitive changes as assessed by Neuropsychological testing
Time frame: Pre and post tDCS; typically within 4 weeks
Cognitive changes as assessed by Neuropsychological testing
Time frame: Pre and post tDCS; typically within 4 weeks
Cognitive changes as assessed by Neuropsychological testing
Time frame: Pre and post tDCS; typically within 4 weeks
Cognitive changes as assessed by Neuropsychological testing
Time frame: Pre and post tDCS; typically within 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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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.
Benjamin Hampstead, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Active tDCS in people with Posttraumatic Stress Disorder (PTSD), run by University of Michigan 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 7 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 31 Aug 2018. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Connectivity changes as assessed by fMRI images (time frame: Pre and post tDCS; typically within 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2018; AzTrials last refreshed its copy on 31 Oct 2026.