Non Invasive Brain Stimulation for PTSD

Posttraumatic Stress Disorder (PTSD) Clinical Trial

Official title:

Non-invasive Brain Stimulation for Post-Traumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442843
• Other study ID #: HUM00089481
• Secondary ID: 1R21MH102539-01
• Status: Completed
• Phase: Early Phase 1
• 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
• 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 .

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

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