Non Invasive Brain Stimulation for PTSD

Early Phase 1

Completed

• Conditions: Posttraumatic Stress Disorder (PTSD)
• Interventions: Device: Sham tDCS; Device: Active tDCS

• Registration Number: NCT02442843
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2015-02-17
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-08
• Study First Posted: 2015-05-13
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

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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 .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham tDCS	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).
active tDCS	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).

Primary Outcome Measures

Name	Time	Method
Functional Connectivity changes as assessed by fMRI images	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 Outcome Measures

Name	Time	Method
Symptomatic changes as assessed by structured questionnaires (CAPS)	Pre and post tDCS; typically within 4 weeks	Clinician administered PTSD Scale
Symptomatic changes as assessed by structured questionnaires (Hamilton Depression Rating Scale)	Pre and post tDCS; typically within 4 weeks	Current symptoms of depression
Symptomatic changes as assessed by structured questionnaires (PCL-C)	Pre and post tDCS; typically within 4 weeks	PTSD checklist
Symptomatic changes as assessed by structured questionnaires (State-trait anxiety inventory)	Pre and post tDCS; typically within 4 weeks	current symptoms of anxiety
Cognitive changes as assessed by Neuropsychological testing	Pre and post tDCS; typically within 4 weeks	Executive functioning (Dimensional change card sort)

Trial Locations

Locations (1)

University of Michigan Neuropsychology Section; 🇺🇸 Ann Arbor, Michigan, United States