Non Invasive Brain Stimulation for PTSD
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: active tDCS 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). |
Device: Active 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.
Other Names:
|
| Sham Comparator: sham tDCS 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). |
Device: Sham 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.
Other Names:
|
| No Intervention: Combat Controls Participants without PTSD will undergo neuropsychological testing and a single fMRI scan. |
Outcome Measures
Primary Outcome Measures
- Functional Connectivity changes as assessed by fMRI images [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.
Secondary Outcome Measures
- Symptomatic changes as assessed by structured questionnaires (PCL-C) [Pre and post tDCS; typically within 4 weeks]
PTSD checklist
- Symptomatic changes as assessed by structured questionnaires (CAPS) [Pre and post tDCS; typically within 4 weeks]
Clinician administered PTSD Scale
- Symptomatic changes as assessed by structured questionnaires (Hamilton Depression Rating Scale) [Pre and post tDCS; typically within 4 weeks]
Current symptoms of depression
- Symptomatic changes as assessed by structured questionnaires (State-trait anxiety inventory) [Pre and post tDCS; typically within 4 weeks]
current symptoms of anxiety
- Cognitive changes as assessed by Neuropsychological testing [Pre and post tDCS; typically within 4 weeks]
Verbal (HVLT) and visuospatial memory (object-location association test)
- Cognitive changes as assessed by Neuropsychological testing [Pre and post tDCS; typically within 4 weeks]
Working memory (n-back)
- Cognitive changes as assessed by Neuropsychological testing [Pre and post tDCS; typically within 4 weeks]
inhibitory control (go/no-go; flanker task; pattern comparison task)
- Cognitive changes as assessed by Neuropsychological testing [Pre and post tDCS; typically within 4 weeks]
Executive functioning (Dimensional change card sort)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male
-
Combat Veteran - both Veterans with and without PTSD will be included at different points in this study
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Right-handed
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Between the ages 18-88
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Stable on medications for a minimum of 2 weeks
Exclusion Criteria:
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a history of neurological disease (e.g., dementia, epilepsy, stroke, moderate - severe traumatic brain injury)
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"severe" Axis I diagnoses (e.g., bipolar disorder, schizophrenia)
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presence of Axis II disorders
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current alcohol or drug abuse/dependence (in the past 8 weeks)
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participants will also be excluded if they are not MRI compatible (assessed using the guidelines of the American College of Radiology)
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Imminent risk of harm to self or others
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history of HIV or sickle cell anemia, as these can cause neuropsychological issues .
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan Neuropsychology Section | Ann Arbor | Michigan | United States | 48105 |
Sponsors and Collaborators
- University of Michigan
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Benjamin Hampstead, PhD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00089481
- 1R21MH102539-01