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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02442843
Other study ID # HUM00089481
Secondary ID 1R21MH102539-01
Status Completed
Phase Early Phase 1
First received
Last updated
Start date May 2015
Est. completion date August 1, 2017

Study information

Verified date August 2018
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date August 1, 2017
Est. primary completion date August 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 88 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of Michigan Neuropsychology Section Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Symptomatic changes as assessed by structured questionnaires (PCL-C) PTSD checklist Pre and post tDCS; typically within 4 weeks
Secondary Symptomatic changes as assessed by structured questionnaires (CAPS) Clinician administered PTSD Scale Pre and post tDCS; typically within 4 weeks
Secondary Symptomatic changes as assessed by structured questionnaires (Hamilton Depression Rating Scale) Current symptoms of depression Pre and post tDCS; typically within 4 weeks
Secondary Symptomatic changes as assessed by structured questionnaires (State-trait anxiety inventory) current symptoms of anxiety Pre and post tDCS; typically within 4 weeks
Secondary Cognitive changes as assessed by Neuropsychological testing Verbal (HVLT) and visuospatial memory (object-location association test) Pre and post tDCS; typically within 4 weeks
Secondary Cognitive changes as assessed by Neuropsychological testing Working memory (n-back) Pre and post tDCS; typically within 4 weeks
Secondary 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
Secondary Cognitive changes as assessed by Neuropsychological testing Executive functioning (Dimensional change card sort) Pre and post tDCS; typically within 4 weeks
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