Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT06705296

Deep Brain Stimulation for Refractory PTSD

Led by Sunnybrook Health Sciences Centre · Updated on 2024-11-26

20

Participants Needed

1

Research Sites

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Deep Brain Stimulation for Refractory PTSD

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 70 years
  • Diagnosis of post-traumatic stress disorder according to DSM-5
  • Persistent PTSD symptoms despite adequate treatment with at least four different therapies including medications and psychotherapy
  • Severe PTSD with Clinician Administered PTSD Scale (CAPS) score of 50 or higher
  • Chronic stable PTSD lasting at least 1 year
  • Ability to give informed consent and follow study procedures and visits
Not Eligible

You will not qualify if you...

  • Any past or current psychosis or mania (patients with depression are allowed)
  • Active neurological diseases such as epilepsy
  • Alcohol or substance abuse or dependence within the last 6 months (excluding caffeine and nicotine)
  • Current suicidal thoughts
  • Contraindications to MRI or PET scans
  • Planning to relocate or move out of the country during the study
  • Medical or neurological conditions increasing surgical risk
  • Currently pregnant or breastfeeding; women of reproductive potential must use effective contraception for at least 1 month before screening and during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

A

Anusha Baskaran, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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