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Device
Deep Brain Stimulation for Autism
N/A
Waitlist Available
Led By George Ibrahim, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trialwill observe the safety and effectiveness of a deep-brain implant to treat autism-related self-injury in 6 children. The implant will last one year. Results will be observed over 36 months.
Who is the study for?
This trial is for children aged 7-18 with Autism Spectrum Disorder who engage in repetitive self-harm and haven't improved after at least 6 months of medical therapy. Participants must have a caregiver able to consent and commit to all study requirements for one year. Exclusions include pregnancy, inability to complete questionnaires in English, potential relocation, certain health risks from surgery, and recent substance abuse.Check my eligibility
What is being tested?
The trial tests the safety and potential effectiveness of Deep Brain Stimulation (DBS) on the nucleus accumbens in children with autism who self-harm despite treatment. Six patients will receive surgical implantation of the Medtronic DBS system over a one-year pilot phase I trial without blinding or randomization.See study design
What are the potential side effects?
Potential side effects may include those associated with brain surgery such as infection risk, bleeding, headache or discomfort at the electrode site; stimulation-related effects like mood changes or seizures; plus device-specific issues like malfunction.
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
Changes in abberant behaviour
Changes in obsessive-compulsive thoughts
Changes in quality of life
+2 moreSecondary outcome measures
Changes in activity
Changes in metabolic brain abnormalities
Changes in number of complications pre and post intervention will be compared.
+2 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%
Productive cough
3%
Ingrowing nail
3%
Respiratory depression
3%
Parkinson's disease
3%
Device migration
3%
Akinesia
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: DBS TreatmentExperimental Treatment2 Interventions
Deep brain stimulation of both limbic and dysfunctional reward processing circuits for treatment of repetitive self injurious behaviours in children with ASD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DBS
2011
Completed Phase 1
~40
Deep Brain Stimulation
2011
Completed Phase 2
~700
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
686 Previous Clinical Trials
6,944,787 Total Patients Enrolled
George Ibrahim, MDPrincipal InvestigatorThe Hospital for Sick Children
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition where you make repetitive movements that can cause self-injury, as determined by your doctor.Parents or guardians who are informed and can give written consent.You have a heart condition, breathing problems, kidney problems, or hormonal issues that would make it risky for you to have surgery.You have a diagnosis of secondary stereotypies, which means you have repetitive movements or behaviors that could result in self-injury. This has been confirmed by your treating physicians and is documented in your medical records.She was able to comply with all testing, follow-ups and study appointments and protocols for 12 months following the end of the duration of the study.You have had problems with drugs or alcohol in the past 6 months, except for caffeine and nicotine.You have a condition that makes it unsafe for you to have an MRI or PET scan.You have been diagnosed with Autism Spectrum Disorder according to the DSM-5 guidelines.If a person's repetitive self-injurious behaviours have not improved after six months of medical therapy, then the therapy is considered to have failed
Research Study Groups:
This trial has the following groups:- Group 1: DBS Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age range for this research study inclusive of individuals aged forty and above?
"This clinical trial is available to those aged 7 and above, but below 18 years of age."
Answered by AI
How many individuals are participating in this experiment?
"Indeed, clinicaltrials.gov states that this research endeavour is still recruiting participants. It was originally published on August 14th 2019 and the most recent update occurred October 24th 2022. Six test subjects are required from a single medical centre."
Answered by AI
Is there an opportunity to join this experiment at present?
"Affirmative. The information provided on clinicaltrials.gov indicates that this investigation is presently looking for volunteers, with the post being posted on August 14th 2019 and most recently updated October 24th 2022. This study necessitates 6 participants from one site to participate."
Answered by AI
Who qualifies to partake in this medical experiment?
"Candidates who meet the criteria of having Autism Spectrum Disorder and are within the ages 7-18 years old can qualify for this clinical trial. Presently, 6 participants need to be recruited."
Answered by AI
Who else is applying?
What state do they live in?
Florida
British Columbia
Colorado
How old are they?
18 - 65
< 18
What site did they apply to?
The Hospital for Sick Children
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
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