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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MH102539-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Combat Controls | No Intervention | Participants without PTSD will undergo neuropsychological testing and a single fMRI scan. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre and post tDCS; typically within 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic changes as assessed by structured questionnaires (PCL-C) | PTSD checklist | Pre and post tDCS; typically within 4 weeks |
| Symptomatic changes as assessed by structured questionnaires (CAPS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Hampstead, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Neuropsychology Section | Ann Arbor | Michigan | 48105 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Sham tDCS | Device | 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. |
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Clinician administered PTSD Scale
| Pre and post tDCS; typically within 4 weeks |
| Symptomatic changes as assessed by structured questionnaires (Hamilton Depression Rating Scale) | Current symptoms of depression | Pre and post tDCS; typically within 4 weeks |
| Symptomatic changes as assessed by structured questionnaires (State-trait anxiety inventory) | current symptoms of anxiety | Pre and post tDCS; typically within 4 weeks |
| Cognitive changes as assessed by Neuropsychological testing | Verbal (HVLT) and visuospatial memory (object-location association test) | Pre and post tDCS; typically within 4 weeks |
| Cognitive changes as assessed by Neuropsychological testing | Working memory (n-back) | 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) | Pre and post tDCS; typically within 4 weeks |
| Cognitive changes as assessed by Neuropsychological testing | Executive functioning (Dimensional change card sort) | Pre and post tDCS; typically within 4 weeks |