Your session is about to expire
← Back to Search
Neurostimulation
Deep Brain Stimulation for PTSD
N/A
Waitlist Available
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A pattern of chronic stable PTSD lasting at least 1 year.
Diagnosis of posttraumatic stress disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM V).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial tests if deep brain stimulation can help people with PTSD symptoms that don't respond to other treatments.
Who is the study for?
This trial is for adults aged 18-70 with severe, chronic PTSD that hasn't improved after trying at least four treatments including SSRIs and cognitive behavioral therapy. Participants must have had stable symptoms for a year or more, score ≥50 on the CAPS scale, and be able to follow the study's procedures.Check my eligibility
What is being tested?
The trial is testing deep brain stimulation (DBS) as a potential treatment for PTSD in patients who haven't responded to standard therapies. It's an early-stage pilot study focusing on safety and how well DBS works when targeting brain areas involved in emotional regulation.See study design
What are the potential side effects?
Potential side effects of DBS can include headache, seizure, confusion, difficulty concentrating, mood changes, infection at the implant site, and hardware-related complications like lead displacement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had PTSD for at least one year.
Select...
I have been diagnosed with PTSD according to DSM V.
Select...
My PTSD is severe, with a CAPS score of 50 or higher.
Select...
I am between 18 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related adverse events using SAFTEE collateral effects scale.
Secondary outcome measures
36-Item Short Form Health Survey (SF-36)
Beck's Anxiety Inventory (BAI)
Beck's Depression Inventory (BDI)
+10 moreSide effects data
From 2018 Phase 2 trial • 53 Patients • NCT0122194823%
Fall
15%
Depression
8%
Hand fracture
8%
Restless legs syndrome
8%
Apathy
5%
Head injury
5%
Dyspepsia
5%
Back pain
5%
Speech disorder
5%
Skeletal injury
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
3%
Pain in extremity
3%
Diabetes mellitus
3%
Intervertebral disc protrusion
3%
Spinal osteoarthritis
3%
Fluid retention
3%
Postoperative wound infection
3%
Osteoarthritis
3%
Macular degeneration
3%
Hypoaesthesia
3%
Ingrowing nail
3%
Respiratory depression
3%
Parkinson's disease
3%
Akinesia
3%
Productive cough
3%
Device migration
3%
Syncope
3%
Diplopia
3%
Skin laceration
3%
Joint sprain
3%
Rib fracture
3%
Drug withdrawal syndrome
3%
Alcohol poisoning
3%
Contusion
3%
Cerebral microangiopathy
3%
Dysarthria
3%
Memory impairment
3%
Movement disorder
3%
Monarthritis
3%
Neck pain
3%
Adverse drug reaction
3%
Cyst
3%
Implant site haematoma
3%
Oedema peripheral
3%
Pyrexia
3%
Pleural effusion
3%
Nerve root lesion
3%
Anxiety
3%
Cough
3%
Fibula fracture
3%
Thermal burn
3%
Sciatica
3%
Anger
3%
Bursitis
3%
Cystitis
3%
Helicobacter gastritis
3%
Implant site infection
3%
Localised infection
3%
Pneumonia
3%
Staphylococcal infection
3%
Confusional state
3%
Depressed mood
3%
Hallucination, auditory
3%
Impulse-control disorder
3%
Insomnia
3%
Panic attack
3%
Rapid eye movements sleep abnormal
3%
Bronchitis
3%
Ear infection
3%
Incision site infection
3%
Arthralgia
3%
Axillary pain
3%
Folate deficiency
3%
Hypertension
3%
Hypotension
3%
Thrombophlebitis
3%
Laboratory test abnormal
3%
Weight increased
3%
Pericardial effusion
3%
Seborrhoeic keratosis
3%
Urinary incontinence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Deep Brain Stimulation
Trial Design
1Treatment groups
Experimental Treatment
Group I: Deep Brain StimulationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~700
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,302 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the target demographic for this research restricted to individuals over fifty years old?
"The minimal age for inclusion in this experiment is 18, while the upper limit is 70."
Answered by AI
Is it possible for me to partake in this trial?
"To participate, potential candidates must have a diagnosis of post-traumatic stress disorder and be between 18 to 70 years old. The trial is currently seeking 5 participants in total."
Answered by AI
Is access to this research currently available for participants?
"Reports from clinicaltrials.gov state that this medical research has stopped recruiting participants--the initial posting was on January 19th, 2018 and the most recent update was March 15th 2021. Fortunately, there are currently 409 other trials actively seeking patients for enrolment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger