NCT03982888Completed
Deep Brain Stimulation in Children With Autism
Deep Brain Stimulation for the Treatment of Refractory Repetitive Self-Injurious Behaviour in Children With Autism Spectrum Disorder: A Pilot Project
Source: ClinicalTrials.gov · Last updated 22 Feb 2024
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety and possible effectiveness of deep brain stimulation (DBS) of the nucleus accumbens in children with autism spectrum disorder and treatment-refractory, repetitive self-injurious behavior. Six (6) patients will be recruited and enrolled in this pilot study and study duration for each patient will be one (1) year. All will undergo surgical implantation of the Medtronic DBS system and will receive stimulation of the nucleus accumbens (2 electrodes per patient).This will be an open, non-blinded, non-randomized, pilot, phase I trial.Expected study duration is 36 months.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 3 Jun 2019
- Start date
- 14 Aug 2019
- Primary completion date
- 1 Jan 2024
- Lead sponsor
- The Hospital for Sick Children
- Diseases
- Autism
- NCT number
- NCT03982888
What you commit to
- Study type: Interventional
- Participants enrolled: 6
- From 14 Aug 2019 to the primary completion date, 1 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure.
Other
- Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
- Any contraindication to MRI or PET scanning
- Likely to relocate away from the study site or move during the study's one year duration
- Pregnancy
- Unable to communicate adequately in English in order to complete the baseline and follow-up questionnaires.
Who the study is looking for
- Female or Male patients between age 7-18
- Diagnosis of Autism Spectrum Disorder (as defined by the DSM-5).
- Failure or non eligibility of medical therapy with ongoing repetitive self-injurious behaviours, at 6 months or more after instigation of therapy. Failure is defined as a lack of improvement in self-injurious behaviours, as documented by objective evidence, including caregiver logs or clinician assessment, if the clinician has documented a baseline status prior to instigation of the medical therapy.
- Diagnosis of secondary stereotypies, based on clinical assessment of the treating physicians with evidence of self-injury, documented in the patient records.
- Parents or legal guardians, including caregivers, informed and able to give written consent.
- 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.
Age in the registry: 7 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.