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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
No Placebo-Only Group
Summary
This trial tests a device that sends electrical signals to the brain to help children with autism who hurt themselves and don't get better with usual treatments. The device aims to calm the brain areas causing these behaviors. This method has shown promise in treating autism by improving behavior.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in abberant behaviour
Changes in obsessive-compulsive thoughts
Changes in quality of life
+2 moreSecondary study objectives
Changes in activity
Changes in metabolic brain abnormalities
Changes in physical brain abnormalities
Side 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%
Back pain
5%
Skeletal injury
5%
Head injury
5%
Speech disorder
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
3%
Osteoarthritis
3%
Postoperative wound infection
3%
Diabetes mellitus
3%
Ingrowing nail
3%
Pain in extremity
3%
Spinal osteoarthritis
3%
Alcohol poisoning
3%
Intervertebral disc protrusion
3%
Hypoaesthesia
3%
Diplopia
3%
Contusion
3%
Productive cough
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%
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: 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
Deep Brain Stimulation
2011
Completed Phase 2
~710
DBS
2011
Completed Phase 1
~40
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Autism Spectrum Disorder (ASD) include behavioral and educational interventions, which focus on modifying behavior through reinforcement techniques and structured learning environments. Deep Brain Stimulation (DBS), specifically targeting the nucleus accumbens, modulates neural activity by delivering electrical impulses to specific brain regions involved in behavior and reward processing.
This can potentially reduce severe repetitive behaviors and self-injury in treatment-refractory cases. Understanding these mechanisms is crucial as they directly influence the neural circuits associated with core ASD symptoms, offering targeted and potentially more effective therapeutic options for patients who do not respond to conventional treatments.
Modulation of Resting-State Brain Complexity After Bilateral Cerebellar Anodal Transcranial Direct Current Stimulation in Children with Autism Spectrum Disorders: a Randomized Controlled Trial Study.
Modulation of Resting-State Brain Complexity After Bilateral Cerebellar Anodal Transcranial Direct Current Stimulation in Children with Autism Spectrum Disorders: a Randomized Controlled Trial Study.
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
711 Previous Clinical Trials
6,958,274 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.