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Procedure
OFF-ON (Sham-Stimulation) for Obsessive-Compulsive Disorder
N/A
Waitlist Available
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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 • 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
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
~700
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment process for this study open to individuals who are older than 85 years of age?
"Individuals aged between 22 and 75 years are eligible for participation in this research investigation. There exist 22 trials targeting those under 18 years old, as well as an additional 79 studies tailored towards individuals over the age of 65."
Answered by AI
Is the enrollment process still open for individuals interested in participating in this trial?
"As per clinicaltrials.gov, this particular research endeavor is presently not open for patient enrollment. The initial posting date was 4/1/2024 with the most recent update on 4/2/2024. Although recruitment is paused, there are a total of 121 alternative studies actively seeking participants."
Answered by AI
Which specific criteria determine the eligibility of individuals to participate in this study?
"Individuals aged between 22 and 75 years with a diagnosis of obsessive-compulsive disorder are eligible for enrollment in this study, which has space for up to 10 participants."
Answered by AI
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