Deep Brain Stimulation of the Amygdala for Combat Post-Traumatic Stress

VA Greater Los Angeles Healthcare System1 site in 1 country6 target enrollmentJanuary 2014

ConditionsPosttraumatic Stress Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Posttraumatic Stress Disorder
Sponsor: VA Greater Los Angeles Healthcare System
Enrollment: 6
Locations: 1
Primary Endpoint: Frequency and Severity of all adverse events
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Posttraumatic stress disorder (PTSD) affects approximately 30 % of American veterans returning from Iraq and Afghanistan. Although the current therapy is effective, a percentage of patients will fail to improve and will develop chronic treatment-resistant PTSD. Patients suffering from PTSD experience intense suffering, lack of productivity and a higher risk of suicide. Unfortunately, combat PTSD has a tendency to be resistant to current treatments.

The central goal of this project is to develop a new therapeutic strategy involving the placement of intracranial electrodes to treat the symptoms of PTSD. The project is based on recent evidence showing abnormal activity in a specific brain region of PTSD patients, thought to be responsible for the core symptoms of PTSD.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

December 31, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

VA Greater Los Angeles Healthcare System

Responsible Party

Principal Investigator

Jean-PhilippeLangevin

Principal Investigator

VA Greater Los Angeles Healthcare System

Eligibility Criteria

Inclusion Criteria

•Male aged 25-70 years.
•Able to give informed consent in accordance with institutional policies and participate in the 2-year follow-up, involving assessments and stimulator adjustments.
•Patients must be stable on their current psychotropic medication for a period of 2 months before implantation and agree to not increase dosages or add any new medications for the first 6 months of the study, unless medically necessary.
•Chart diagnosis of chronic and treatment-refractory PTSD as the principal psychiatric diagnosis and cause of distress and social/occupational impairment.
•Confirmation of PTSD as the primary psychiatric diagnosis by the study psychiatrist via clinical interview and CAPS.
•Confirmation of combat trauma exposure via military record review and a Combat Exposure Scale score \>
•Minimum 5 year total illness duration, with no 6 month period of clinical remission during the 5 years prior to entry in the study.
•Clinical record documentation of non-response to at least 2 of the following antidepressants, alone or in combination, at maximally tolerated FDA recommended doses for ≥ 6 months: sertraline, paroxetine, fluoxetine, citalopram, escitalopram, amitriptyline, imipramine, nortriptyline, desipramine, clomipramine, phenelzine, tranylcypromine, venlafaxine, mirtazapine. Antidepressant trials must include at least one SSRI and one SNRI or TCA at maximally tolerated FDA recommended doses for a minimum of 3 months.
•A minimum 3 month trial of prazosin at 10 mg per day or, if less, maximally tolerated FDA recommended doses, unless considered contraindicated based on co-morbid medical conditions or concomitant medications.
•Trial of at least 3 months of one of the following: lithium, divalproex sodium, carbamazepine, lamotrigine, olanzapine, risperidone, bupropion either alone or in conjunction with one or more of the agents in #8 and # 9 above.

Exclusion Criteria

•Suicide attempt in the last 2 years and/or presence of a suicide plan (an answer of "Yes" to Question C4 in Section C-Suicidality of MINI International Neuropsychiatric Interview);
•Psychosis or bipolar disorder; significant acute or ongoing risk for violence;
•Patients primarily diagnosed with DSM-IV-TR Axis I disorder other than PTSD as determined by the MINI;
•Within the 3 months prior to enrolment, subject has started a new psychotherapy program;
•Alcohol or illicit substance use disorder within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance use disorder could account for lack of treatment response;
•Current significant neurological conditions, including epilepsy, stroke, movement disorder; history of serious head injury with loss of consciousness
•Patients with uncontrolled medical conditions (hypertension, diabetes, infection);
•Uncontrolled chronic pain;
•Baseline Montgomery Asberg Depression Rating Scale (MADRS) of ≥ 28;
•Patients who are receiving anticoagulation therapy;