Clinical trial NCT03416894: Deep Brain Stimulation for Treatment Refractory PTSD
Official title: Deep Brain Stimulation (DBS) for the Treatment of Refractory Post-Traumatic Stress Disorder (PTSD): Pilot Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants with treatment-related adverse events using SAFTEE collateral effects scale.
timeFrame: 1 year
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HAMD)
timeFrame: 1 year
measure: Beck's Depression Inventory (BDI)
timeFrame: 1 year
measure: Beck's Anxiety Inventory (BAI)
timeFrame: 1 year
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: 1 year
measure: Davidson Trauma Scale (DTS)
timeFrame: 1 year
measure: Short PTSD Rating Interview (SPRINT)
timeFrame: 1 year
measure: Clinical Global Impression (CGI)
timeFrame: 1 year
measure: Global Functioning Assessment (GFA)
timeFrame: 1 year
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: 1 year
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: 1 year
measure: Hamilton Anxiety Rating Scale (HAMA)
timeFrame: 1 year
measure: Sheehan disability scale (SDS)
timeFrame: 1 year
measure: Positive and negative affect (PANAS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References: