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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
No Placebo-Only Group
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.
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.
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.
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I have been diagnosed with PTSD according to DSM V.
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My PTSD is severe, with a CAPS score of 50 or higher.
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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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with treatment-related adverse events using SAFTEE collateral effects scale.
Secondary study objectives
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%
Dyspepsia
5%
Skeletal injury
5%
Back pain
5%
Head injury
5%
Speech disorder
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
3%
Macular degeneration
3%
Postoperative wound infection
3%
Ingrowing nail
3%
Hypoaesthesia
3%
Joint sprain
3%
Fluid retention
3%
Alcohol poisoning
3%
Contusion
3%
Intervertebral disc protrusion
3%
Diplopia
3%
Pain in extremity
3%
Osteoarthritis
3%
Spinal osteoarthritis
3%
Productive cough
3%
Diabetes mellitus
3%
Device migration
3%
Skin laceration
3%
Akinesia
3%
Parkinson's disease
3%
Syncope
3%
Respiratory depression
3%
Rib fracture
3%
Drug withdrawal syndrome
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~710
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
681 Previous Clinical Trials
1,565,753 Total Patients Enrolled