What side effects are associated with this type of intervention?

Deep Brain Stimulation (DBS) for autism, particularly targeting the nucleus accumbens, is an invasive procedure that can cause several side effects. These include infection, hemorrhage, confusion, and seizures. Hardware malfunctions are also common but generally correctable. Stimulation-related complications are usually reversible by adjusting the stimulation parameters. Other common treatments for autism, such as behavioral therapies and medications, may have side effects like gastrointestinal issues, sleep disturbances, and changes in appetite or weight.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments for autism that involve deep brain stimulation (DBS) or similar neuromodulatory techniques. The primary FDA-approved medications for autism are antipsychotics like risperidone and aripiprazole, which are used to manage irritability and aggression associated with the condition. Research into neuromodulatory treatments, such as DBS targeting the nucleus accumbens, is ongoing and remains experimental at this stage.

What other types of research exist?

Promising, novel alternatives to Deep Brain Stimulation for autism patients include: 1) Transcranial Direct Current Stimulation (tDCS), which uses a weak electric current to modulate brain activity and has shown potential in improving cognitive and behavioral symptoms. 2) Repetitive Transcranial Magnetic Stimulation (rTMS), which uses magnetic fields to stimulate nerve cells in the brain and has been explored for various neuropsychiatric conditions. Both methods are non-invasive and have emerging evidence supporting their use in neurodevelopmental disorders.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 more

Secondary 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 • NCT01221948

23%

Fall

15%

Depression

Hand fracture

Restless legs syndrome

Apathy

Dyspepsia

Back pain

Skeletal injury

Head injury

Speech disorder

Tremor

Gait disturbance

Dystonia

Paraesthesia

Influenza

Urinary tract infection

Osteoarthritis

Ingrowing nail

Postoperative wound infection

Diabetes mellitus

Pain in extremity

Spinal osteoarthritis

Alcohol poisoning

Intervertebral disc protrusion

Hypoaesthesia

Diplopia

Contusion

Productive cough

Joint sprain

Macular degeneration

Fluid retention

Device migration

Skin laceration

Akinesia

Parkinson's disease

Syncope

Respiratory depression

Rib fracture

Drug withdrawal syndrome

Cerebral microangiopathy

Dysarthria

Memory impairment

Movement disorder

Monarthritis

Neck pain

Adverse drug reaction

Cyst

Implant site haematoma

Oedema peripheral

Pyrexia

Pleural effusion

Nerve root lesion

Anxiety

Cough

Fibula fracture

Thermal burn

Sciatica

Anger

Bursitis

Cystitis

Helicobacter gastritis

Implant site infection

Localised infection

Pneumonia

Staphylococcal infection

Confusional state

Depressed mood

Hallucination, auditory

Impulse-control disorder

Insomnia

Panic attack

Rapid eye movements sleep abnormal

Bronchitis

Ear infection

Incision site infection

Arthralgia

Axillary pain

Folate deficiency

Hypertension

Hypotension

Thrombophlebitis

Laboratory test abnormal

Weight increased

Pericardial effusion

Seborrhoeic keratosis

Urinary incontinence

100%

80%

60%

40%

20%

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

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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.