Non Invasive Brain Stimulation for PTSD

Early Phase 1CompletedNCT02442843

University of Michigan18 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Posttraumatic Stress Disorder (PTSD)

Interventions

Active tDCSDEVICE

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 tDCSDEVICE

Eligibility

Sex: MALEMin age: 18 YearsMax age: 88 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 .

Locations (1)

University of Michigan Neuropsychology Section

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.