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Non Invasive Brain Stimulation for PTSD

Primary Purpose

Posttraumatic Stress Disorder (PTSD)

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder (PTSD)

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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 .

Sites / Locations

  • University of Michigan Neuropsychology Section

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

active tDCS

sham tDCS

Combat Controls

Arm Description

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).

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).

Participants without PTSD will undergo neuropsychological testing and a single fMRI scan.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Symptomatic changes as assessed by structured questionnaires (PCL-C)
PTSD checklist
Symptomatic changes as assessed by structured questionnaires (CAPS)
Clinician administered PTSD Scale
Symptomatic changes as assessed by structured questionnaires (Hamilton Depression Rating Scale)
Current symptoms of depression
Symptomatic changes as assessed by structured questionnaires (State-trait anxiety inventory)
current symptoms of anxiety
Cognitive changes as assessed by Neuropsychological testing
Verbal (HVLT) and visuospatial memory (object-location association test)
Cognitive changes as assessed by Neuropsychological testing
Working memory (n-back)
Cognitive changes as assessed by Neuropsychological testing
inhibitory control (go/no-go; flanker task; pattern comparison task)
Cognitive changes as assessed by Neuropsychological testing
Executive functioning (Dimensional change card sort)

Full Information

First Posted
February 17, 2015
Last Updated
August 28, 2018
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02442843
Brief Title
Non Invasive Brain Stimulation for PTSD
Official Title
Non-invasive Brain Stimulation for Post-Traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder (PTSD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active tDCS
Arm Type
Experimental
Arm Description
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).
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
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).
Arm Title
Combat Controls
Arm Type
No Intervention
Arm Description
Participants without PTSD will undergo neuropsychological testing and a single fMRI scan.
Intervention Type
Device
Intervention Name(s)
Active tDCS
Other Intervention Name(s)
mild brain stimulation, HD-tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Other Intervention Name(s)
fake tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Connectivity changes as assessed by fMRI images
Description
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
Secondary Outcome Measure Information:
Title
Symptomatic changes as assessed by structured questionnaires (PCL-C)
Description
PTSD checklist
Time Frame
Pre and post tDCS; typically within 4 weeks
Title
Symptomatic changes as assessed by structured questionnaires (CAPS)
Description
Clinician administered PTSD Scale
Time Frame
Pre and post tDCS; typically within 4 weeks
Title
Symptomatic changes as assessed by structured questionnaires (Hamilton Depression Rating Scale)
Description
Current symptoms of depression
Time Frame
Pre and post tDCS; typically within 4 weeks
Title
Symptomatic changes as assessed by structured questionnaires (State-trait anxiety inventory)
Description
current symptoms of anxiety
Time Frame
Pre and post tDCS; typically within 4 weeks
Title
Cognitive changes as assessed by Neuropsychological testing
Description
Verbal (HVLT) and visuospatial memory (object-location association test)
Time Frame
Pre and post tDCS; typically within 4 weeks
Title
Cognitive changes as assessed by Neuropsychological testing
Description
Working memory (n-back)
Time Frame
Pre and post tDCS; typically within 4 weeks
Title
Cognitive changes as assessed by Neuropsychological testing
Description
inhibitory control (go/no-go; flanker task; pattern comparison task)
Time Frame
Pre and post tDCS; typically within 4 weeks
Title
Cognitive changes as assessed by Neuropsychological testing
Description
Executive functioning (Dimensional change card sort)
Time Frame
Pre and post tDCS; typically within 4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Hampstead, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Neuropsychology Section
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

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Non Invasive Brain Stimulation for PTSD

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