Deep Brain Stimulation for Treatment Refractory PTSD

NCT ID: NCT03416894

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-19
• Study Completion Date: 2024-11-10

Brief Summary

This is a phase I, non-blinded, non-randomized, pilot trial for safety and efficacy of deep brain stimulation for PTSD. A substantial number of individuals continue to experience PTSD symptoms despite appropriate medical treatment. In psychotherapy-based studies, over 30% of patients that completed a full course of treatment continue to meet criteria for PTSD. Response rates to treatment with SSRIs are usually no higher than 60%. This study would be the first exploration of a surgical therapy for refractory PTSD. The subgenual cingulate plays a role in mechanisms of this disorders and has been successfully targeted with DBS for the treatment of depression. The development of a therapy that targets brain structures known to play a role in this disease would be a substantial step forward in the treatment and understanding of these conditions.

Conditions

Post-Traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Deep Brain Stimulation

Group Type: EXPERIMENTAL

Deep Brain Stimulation

Intervention Type: DEVICE

DBS offers the opportunity to insert electrodes into deep brain structures and electrically stimulate them in a titratable and ultimately reversible manner

Interventions

Deep Brain Stimulation

DBS offers the opportunity to insert electrodes into deep brain structures and electrically stimulate them in a titratable and ultimately reversible manner

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Female or Male patients between age 18-70

2. Diagnosis of posttraumatic stress disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM V).

3. Treatment Resistance as defined by the persistence of clinical symptoms despite adequate treatment with four modalities, including a) selective serotonin reuptake inhibitors, b) cognitive behavioral therapy, c) other classes of medications and/or psychotherapy.

4. Severe forms of the disease as measured by Clinician Administered PTSD scale (CAPS) scores ≥ 50.

5. A pattern of chronic stable PTSD lasting at least 1 year.

6. Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols

Exclusion Criteria

1. Any past or current evidence of psychosis or mania (patients with co-morbid depression will not be excluded from the study)

2. Active neurologic disease, such as epilepsy

3. Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine

4. Current suicidal ideation

5. Any contraindication to MRI or PET scanning

6. Likely to relocate or move out of the country during the study's one year duration

7. Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.

8. Currently pregnant (as determined by history and serum HCG) or lactating; for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Nir Lipsman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

165-2017

Identifier Type: -

Identifier Source: org_study_id