NCT03416894

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

January 19, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2024

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

6.8 years

First QC Date

January 8, 2018

Last Update Submit

December 1, 2023

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-related adverse events using SAFTEE collateral effects scale.

    Adverse events (AE) will be recorded and categorized according to severity and relationship to procedure. All AEs will be assessed for their relationship to the study procedure.

    1 year

Secondary Outcomes (13)

  • Hamilton Depression Rating Scale (HAMD)

    1 year

  • Beck's Depression Inventory (BDI)

    1 year

  • Beck's Anxiety Inventory (BAI)

    1 year

  • Clinician-Administered PTSD Scale (CAPS)

    1 year

  • Davidson Trauma Scale (DTS)

    1 year

  • +8 more secondary outcomes

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL
Device: Deep Brain Stimulation

Interventions

Deep Brain StimulationDEVICE

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

Deep Brain Stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female or Male patients between age 18-70
  • Diagnosis of posttraumatic stress disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM V).
  • 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.
  • Severe forms of the disease as measured by Clinician Administered PTSD scale (CAPS) scores ≥ 50.
  • A pattern of chronic stable PTSD lasting at least 1 year.
  • Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols

You may not qualify if:

  • Any past or current evidence of psychosis or mania (patients with co-morbid depression will not be excluded from the study)
  • Active neurologic disease, such as epilepsy
  • Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
  • Current suicidal ideation
  • Any contraindication to MRI or PET scanning
  • Likely to relocate or move out of the country during the study's one year duration
  • Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 31, 2018

Study Start

January 19, 2018

Primary Completion

November 10, 2024

Study Completion

November 10, 2024

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)