University of Michigan Neuropsychology Section
Ann Arbor, Michigan, 48105, United States
NCT Number: NCT02442843
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.
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Notify Me18 year–88 year
Male
Interventional
Early Phase 1
Ann Arbor, Michigan, 48105, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: 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.
Other names: fake tDCS
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.
Time frame: Pre and post tDCS; typically within 4 weeks
PTSD checklist
Time frame: Pre and post tDCS; typically within 4 weeks
Clinician administered PTSD Scale
Time frame: Pre and post tDCS; typically within 4 weeks
Current symptoms of depression
Time frame: Pre and post tDCS; typically within 4 weeks
current symptoms of anxiety
Time frame: Pre and post tDCS; typically within 4 weeks
Verbal (HVLT) and visuospatial memory (object-location association test)
Time frame: Pre and post tDCS; typically within 4 weeks
Working memory (n-back)
Time frame: Pre and post tDCS; typically within 4 weeks
inhibitory control (go/no-go; flanker task; pattern comparison task)
Time frame: Pre and post tDCS; typically within 4 weeks
Executive functioning (Dimensional change card sort)
University of Michigan
Other
Non-invasive Brain Stimulation for Post-Traumatic Stress Disorder
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