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Procedure

Deep Brain Stimulation for Obsessive-Compulsive Disorder

N/A
Recruiting
Led By A Moses Lee, MD, PhD
Research Sponsored by Andrew Moses Lee, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 years
Awards & highlights

Summary

This trial is testing a new treatment for OCD using deep brain stimulation (DBS) guided by SEEG. The study will have three stages: brain mapping and parameter optimization, DBS surgery with stimulation

Who is the study for?
This trial is for individuals with severe Obsessive-Compulsive Disorder (OCD) that hasn't improved with standard treatments. Participants must be suitable for brain surgery and willing to undergo detailed brain mapping, as well as a follow-up period involving both blinded and open label treatment phases.
What is being tested?
The study tests Deep Brain Stimulation (DBS), where electrodes are placed in specific brain areas to control OCD symptoms. It's a three-stage process including initial brain mapping, surgical implantation of stimulation devices, and a randomized crossover phase followed by an open label treatment.
What are the potential side effects?
Potential side effects may include risks associated with brain surgery such as infection or bleeding, changes in mood or behavior due to stimulation, headache, discomfort at the device site, and possible temporary worsening of OCD symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy Endpoint - Treatment Response
Primary Feasibility Endpoint #1 - Stimulation Target That Acutely Improves OCD Symptoms
Primary Feasibility Endpoint #2 - Identifying an electrophysiological biomarker of OCD
+3 more
Secondary study objectives
Secondary Efficacy Endpoint #1 - Improvement in YBOCS scores from Baseline
Secondary Efficacy Endpoint #2 - Improvement in OCD Symptoms from Baseline
Secondary Efficacy Endpoint #3 - Improvement in Depression Symptoms from Baseline

Side effects data

From 2018 Phase 2 trial • 53 Patients • NCT01221948
23%
Fall
15%
Depression
8%
Hand fracture
8%
Restless legs syndrome
8%
Apathy
5%
Skeletal injury
5%
Dyspepsia
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%
Contusion
3%
Alcohol poisoning
3%
Hypoaesthesia
3%
Diplopia
3%
Joint sprain
3%
Macular degeneration
3%
Fluid retention
3%
Device migration
3%
Skin laceration
3%
Akinesia
3%
Parkinson's disease
3%
Syncope
3%
Respiratory depression
3%
Productive cough
3%
Diabetes mellitus
3%
Ingrowing nail
3%
Postoperative wound infection
3%
Intervertebral disc protrusion
3%
Osteoarthritis
3%
Pain in extremity
3%
Spinal osteoarthritis
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

Trial Design

2Treatment groups
Experimental Treatment
Group I: ON-OFF (Stimulation-Sham)Experimental Treatment1 Intervention
Patients in the ON-OFF arm will first be treated for up to 12 weeks with the parameters identified during the DBS optimization phase until the washout period.
Group II: OFF-ON (Sham-Stimulation)Experimental Treatment1 Intervention
Patients in the OFF-ON will have their devices turned off and will not have their device switched on (activated) until the crossover point.
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?

Andrew Moses Lee, MD, PhDLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
15 Patients Enrolled for Obsessive-Compulsive Disorder
A Moses Lee, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
Andrew Krystal, MDPrincipal InvestigatorUniversity of California, San Francisco
6 Previous Clinical Trials
690 Total Patients Enrolled
~7 spots leftby May 2028
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