Effect of rTMS on the Abnormal Executive Function of ASD Children

NCT04237870 | Unknown

• 1 other identifier: XH-19-013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will explore the effects of repetitive transcranial magnetic stimulation (rTMS) on executive function deficits in high function autism spectrum disorder. Half of the participants will be chosen by chance to receive continuous theta burst stimulation (cTBS) while the other half will be chosen by chance to receive sham stimulation. And finally the sham group individuals also receive cTBS. Based on results from a recent unpublished pilot data, the investigators propose that cTBS treatment will induce a significant improvement in executive function performance compared to sham treatment.

Conditions

Executive Dysfunction; ASD

Outcome Measures

Primary Outcomes (1)

• Change in scores on Behaviour Rating Inventory of Executive Functioning (BRIEF)

  Specifically the investigators will evaluate the changes in executive function (EF) scores before and after cTBS treatment.

  Baseline; Post cTBS (4 weeks after baseline

Secondary Outcomes (2)

• Change in scores, reaction time and brain blood flow on the Working Memory Task by fNIRS

  Baseline; Post cTBS (4 weeks after baseline)

• Change in size and connections of different parts of the brain to assess brain structure and blood flow by functional magnetic resonance imaging (fMRI)

  Baseline; Post cTBS (4 weeks after baseline)

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Active cTBS treatment will be delivered at an intensity that is 70% of the resting motor threshold (RMT). cTBS consist of bursts of 3 magnetic pulses at 30 Hz repeating every 200 ms for 300 pulses. cTBS repeat twice with 15 min interval. Treatment will be applied in central suleus.

Device: Active cTBS

Sham treatment

SHAM COMPARATOR

Sham rTMS will be delivered using the same stimulation parameters and at the site of active treatment, but with only the side-edge resting on the scalp. The coil will be angled 45 degrees way from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g. contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.

Device: Sham

Interventions

Active cTBS DEVICE

Active cTBS treatment will be delivered at an intensity that is 70% of the resting motor threshold (RMT). cTBS consist of bursts of 3 magnetic pulses at 30 Hz repeating every 200 ms for 300 pulses. cTBS will be repeated twice with 15 min interval. The cTBS sessions last for 4 weeks, 5 times a week. Treatment will be applied to central suleus.

Also known as: magstim Rapid2 (Magstim Company Ltd. UK)

Active treatment

Sham DEVICE

Sham stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but with only the side-edge resting on the scalp. The coil will be angled 45 degrees way from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g. contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.

Also known as: magstim Rapid2 (Magstim Company Ltd. UK)

Sham treatment

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients diagnosed with ASD. Diagnostic criteria: diagnosed by pediatric psychiatrists in accordance with the criteria in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V), Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview-Revised (ADI-R);
• Have a diagnosis of high functioning ASD (HF-ASD) (i.e., are verbal with an Intelligence Quotient (IQ) ≥ 70)
• Are clinically stable as determined by their treating physician, with no medication changes over the past 4 weeks

You may not qualify if:

• Have metal or electronic instruments near the stimulation brain area of coil, such as, have intravascular stent in head, have metal objects in skull.
• Have cardiac pacemaker, cochlear implant, medical pump;
• Can not cooperate with examiner;
• Have intracranial foreign bodies by craniotomy, or intracranial deformity
• Have a history of substance abuse or dependence in the last 6 months or have a positive urine toxicology screen
• Have a concomitant major medical or neurologic illness
• Have had a seizure in the past, or have a first-degree relative with epilepsy
• Have an abnormal clinical EEG
• Are pregnant or likely to get pregnant during the next 4 weeks
• Have a history of rTMS treatment.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Fei Li

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Study Officials

• Fei Li, PhD, MD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Li, PHD, MD

CONTACT

+86-21-25077461; feili@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 23, 2020
• Study Start: January 1, 2019
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)