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Completed

NCT Number: NCT02442843

Non Invasive Brain Stimulation for PTSD

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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Key information

Age range

18 year–88 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Michigan Neuropsychology Section

Ann Arbor, Michigan, 48105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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 .

Treatment and study plan

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.

Other names: mild brain stimulation, HD-tDCS

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.

Other names: fake tDCS

Primary outcomes

  1. 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.

Secondary outcomes

  1. Symptomatic changes as assessed by structured questionnaires (PCL-C)

    Time frame: Pre and post tDCS; typically within 4 weeks

    PTSD checklist

  2. Symptomatic changes as assessed by structured questionnaires (CAPS)

    Time frame: Pre and post tDCS; typically within 4 weeks

    Clinician administered PTSD Scale

  3. Symptomatic changes as assessed by structured questionnaires (Hamilton Depression Rating Scale)

    Time frame: Pre and post tDCS; typically within 4 weeks

    Current symptoms of depression

  4. Symptomatic changes as assessed by structured questionnaires (State-trait anxiety inventory)

    Time frame: Pre and post tDCS; typically within 4 weeks

    current symptoms of anxiety

  5. Cognitive changes as assessed by Neuropsychological testing

    Time frame: Pre and post tDCS; typically within 4 weeks

    Verbal (HVLT) and visuospatial memory (object-location association test)

  6. Cognitive changes as assessed by Neuropsychological testing

    Time frame: Pre and post tDCS; typically within 4 weeks

    Working memory (n-back)

  7. Cognitive changes as assessed by Neuropsychological testing

    Time frame: Pre and post tDCS; typically within 4 weeks

    inhibitory control (go/no-go; flanker task; pattern comparison task)

  8. Cognitive changes as assessed by Neuropsychological testing

    Time frame: Pre and post tDCS; typically within 4 weeks

    Executive functioning (Dimensional change card sort)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Non-invasive Brain Stimulation for Post-Traumatic Stress Disorder

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 13, 2015
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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