Deep Brain Stimulation for Autism

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Autism+2 MoreDeep Brain Stimulation - Procedure
Eligibility
7 - 18
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether deep brain stimulation of the nucleus accumbens might be safe and effective for treating children with autism spectrum disorder and treatment-refractory, repetitive self-injurious behavior.

Eligible Conditions
  • Autism
  • Self-Harm

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 5 Secondary · Reporting Duration: 1 year

1 year
Changes in abberant behaviour
Changes in activity
Changes in metabolic brain abnormalities
Changes in number of complications pre and post intervention will be compared.
Changes in obsessive-compulsive thoughts
Changes in physical brain abnormalities
Changes in quality of life
Changes in repetitive behaviour
Changes in self-injurious behaviour
Type of adverse events reported in caregiver logs

Trial Safety

Safety Progress

1 of 3

Side Effects for

Deep Brain Stimulation
23%Fall
15%Depression
8%Restless legs syndrome
8%Apathy
8%Hand fracture
5%Urinary tract infection
5%Speech disorder
5%Influenza
5%Head injury
5%Dystonia
5%Tremor
5%Gait disturbance
5%Skeletal injury
5%Paraesthesia
5%Back pain
5%Dyspepsia
3%Rapid eye movements sleep abnormal
3%Ingrowing nail
3%Hallucination, auditory
3%Impulse-control disorder
3%Insomnia
3%Panic attack
3%Depressed mood
3%Confusional state
3%Implant site infection
3%Localised infection
3%Staphylococcal infection
3%Device migration
3%Joint sprain
3%Skin laceration
3%Parkinson's disease
3%Syncope
3%Fibula fracture
3%Rib fracture
3%Memory impairment
3%Movement disorder
3%Nerve root lesion
3%Sciatica
3%Bronchitis
3%Ear infection
3%Incision site infection
3%Bursitis
3%Intervertebral disc protrusion
3%Neck pain
3%Pain in extremity
3%Spinal osteoarthritis
3%Adverse drug reaction
3%Axillary pain
3%Drug withdrawal syndrome
3%Implant site haematoma
3%Oedema peripheral
3%Productive cough
3%Diabetes mellitus
3%Fluid retention
3%Folate deficiency
3%Macular degeneration
3%Laboratory test abnormal
3%Pericardial effusion
3%Seborrhoeic keratosis
3%Urinary incontinence
3%Respiratory depression
3%Anxiety
3%Cyst
3%Hypertension
3%Hypotension
3%Pneumonia
3%Cystitis
3%Akinesia
3%Helicobacter gastritis
3%Alcohol poisoning
3%Thermal burn
3%Cerebral microangiopathy
3%Hypoaesthesia
3%Contusion
3%Dysarthria
3%Anger
3%Postoperative wound infection
3%Arthralgia
3%Cough
3%Pleural effusion
3%Monarthritis
3%Osteoarthritis
3%Diplopia
3%Pyrexia
3%Weight increased
3%Thrombophlebitis
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01221948) in the Deep Brain Stimulation ARM group. Side effects include: Fall with 23%, Depression with 15%, Restless legs syndrome with 8%, Apathy with 8%, Hand fracture with 8%.

Trial Design

1 Treatment Group

DBS Treatment
1 of 1

Experimental Treatment

6 Total Participants · 1 Treatment Group

Primary Treatment: Deep Brain Stimulation · No Placebo Group · N/A

DBS TreatmentExperimental Group · 2 Interventions: Deep Brain Stimulation, DBS · Intervention Types: Procedure, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~700
DBS
2011
Completed Phase 1
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
642 Previous Clinical Trials
6,816,513 Total Patients Enrolled
George Ibrahim, MDPrincipal InvestigatorThe Hospital for Sick Children

Eligibility Criteria

Age 7 - 18 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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
The diagnosis of secondary stereotypies was made by clinical assessment of the treating physicians, who found evidence of self-injury in the patient records.
Parents or guardians who are informed and can give written consent.
The DSM-5 defines Autism Spectrum Disorder as a developmental disorder that affects communication and behavior
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.

Who else is applying?

What state do they live in?
Colorado33.3%
Florida33.3%
British Columbia33.3%
How old are they?
18 - 6540.0%
< 1860.0%
What site did they apply to?
The Hospital for Sick Children100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%