Non Invasive Brain Stimulation for PTSD

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder (PTSD)
• Intervention / Treatment: Device: Active tDCS; Device: Sham tDCS

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan Neuropsychology Section

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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:

1. a history of neurological disease (e.g., dementia, epilepsy, stroke, moderate - severe traumatic brain injury)
2. "severe" Axis I diagnoses (e.g., bipolar disorder, schizophrenia)
3. presence of Axis II disorders
4. current alcohol or drug abuse/dependence (in the past 8 weeks)
5. participants will also be excluded if they are not MRI compatible (assessed using the guidelines of the American College of Radiology)
6. Imminent risk of harm to self or others
7. history of HIV or sickle cell anemia, as these can cause neuropsychological issues .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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: HD-tDCS; mild brain stimulation
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: fake tDCS
No Intervention: Combat Controls; Participants without PTSD will undergo neuropsychological testing and a single fMRI scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Benjamin Hampstead, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: February 17, 2015
• First Submitted That Met QC Criteria: May 8, 2015
• First Posted (Estimate): May 13, 2015

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: HUM00089481; 1R21MH102539-01 (U.S. NIH Grant/Contract)