Non Invasive Brain Stimulation for PTSD

NCT02442843 | Completed Early Phase 1

• 2 other identifiers: HUM000894811R21MH102539-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder (PTSD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Symptomatic changes as assessed by structured questionnaires (PCL-C)

  Pre and post tDCS; typically within 4 weeks

• Symptomatic changes as assessed by structured questionnaires (CAPS)

  Pre and post tDCS; typically within 4 weeks

• Symptomatic changes as assessed by structured questionnaires (Hamilton Depression Rating Scale)

  Pre and post tDCS; typically within 4 weeks

• Symptomatic changes as assessed by structured questionnaires (State-trait anxiety inventory)

  Pre and post tDCS; typically within 4 weeks

• Cognitive changes as assessed by Neuropsychological testing

  Pre and post tDCS; typically within 4 weeks

Study Arms (3)

active tDCS

EXPERIMENTAL

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

sham tDCS

SHAM COMPARATOR

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

Combat Controls

NO INTERVENTION

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

Interventions

Active tDCS DEVICE

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.

Also known as: mild brain stimulation, HD-tDCS

active tDCS

Sham tDCS DEVICE

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.

Also known as: fake tDCS

sham tDCS

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Michigan Neuropsychology Section

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Benjamin Hampstead, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: May 13, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

US (1)