Recruiting
Phase 1

Deep Brain Stimulation

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06705296

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Open Label Deep Brain Stimulation

Double blinded Deep Brain Stimulation

Prolonged exposure therapy

Closed loop Deep brain stimulation

Study Details

Brief summary:

Treatment refractory PTSD is a chronic and debilitating psychiatric disorder associated with high morbidity. Despite advances in neuroimaging, genetics, pharmacology and psychosocial interventions in the last half century, little progress has been made in altering the natural history of the condition or its outcome.

This study would be the first exploration of a surgical therapy for refractory PTSD. The subgenual cingulate plays a role in mechanisms of this disorder and has been successfully targeted with DBS for the treatment of depression

The study will proceed in three stages: pre-operative, operative and post-operative. In the pre-operative stage, consent will be obtained and patients will be scheduled for additional investigations, including neuroimaging (MRI), neuropsychological testing, psychophysiological testing, and a pre-operative assessment by the anesthesia service.

In the operative stage, patient will have a stereotactic frame attached directly to their skull. The patient will then undergo a computed tomography (CT) scan with the frame in place, followed by transport directly to the operating room. A skin incision will be made and two burr holes drilled through the skull. After target identification DBS electrodes will be inserted and fixed in place. Patients will be then immediately anesthetized (general anesthesia) for the next step of the surgery. This will involve implanting an internal pulse generator (IPG) under the collarbone and connecting it to the DBS electrodes.

During the post-operative phase, patients will return to the clinic 2 weeks after surgery.DBS programming visits will happen biweekly for three months, and monthly thereafter.

Conditions

PTSD

Study ID

NCT06705296

Start date

Nov 1, 2024

Status verified date

Nov, 2024

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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-5).
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 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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open label

1) Open label phase (from surgery until postoperative week 24)

placebo comparator: Double-blinded "on/off" phase

Double-blinded "on/off" phase (from postoperative week 25 to 33)

experimental: Prolonged exposure therapy

Prolonged exposure therapy (from postoperative week 34to 44)

experimental: Closed-loop DBS

Closed-loop DBS (from postoperative week 45 to 60).

Interventions

Open Label Deep Brain Stimulation

Patients will receive open label deep brain stimulation

Double blinded Deep Brain Stimulation

Patients will receive double blinded deep brain stimulation

Prolonged exposure therapy

Patients will receive prolonged exposure therapy

Closed loop Deep brain stimulation

Patients will receive closed loop deep brain stimulation

Primary outcome measure

  • Number of participants with treatment-related adverse events as assessed by SAFTEE [ Time Frame: Every 2 weeks until the 8 weeks mark, every 4 weeks until 6 month mark and every two months until the 2 year mark ]
  • Clinician-Administered PTSD Scale for DSM-5 (CAPS) [ Time Frame: Every 2 weeks until the 8 weeks mark, every 4 weeks until 6 month mark and every two months until the 2 year mark ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Nov 26, 2024

Last verified

Nov, 2024

Keywords

  • PTSD
  • DBS
  • Post Traumatic Stress Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2024-11-26.