Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behaviors in Autism

NCT01983189 | Terminated Phase 2 DMC

• 1 other identifier: 5594
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a trial of low frequency Repetitive Transcranial magnetic stimulation( rTMS) for subjects with autism spectrum disorders, specially targeting repetitive behaviors.

Conditions

Autism; Asperger Disorder; Other Developmental Pervasive Disorder

Keywords

TMS; transcranial magnetic stimulation; rTMS; recurrent transcranial magnetic stimulation; fMRI; functional magnetic resonance imaging.

Outcome Measures

Primary Outcomes (1)

• clinical improvement based on repetitive behavior scale.

  baseline-week3

Secondary Outcomes (1)

• clinical improvement based on the social responsiveness scale.

  before-week3

Study Arms (1)

Low frequency rTMS

EXPERIMENTAL

low frequency, repetitive transcranial magnetic stimulation (rTMS) for 20 minutes daily, 5 times a week for 3 weeks

Procedure: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation PROCEDURE

1 hz transcranial magnetic stimulation

Low frequency rTMS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• English Speaking
• Capacity to give consent and sign HIPAA Authorization
• Patients currently taking psychotropic medications must be at the same stable dose and likely to be able to continue at the same dose throughout the study
• ASD diagnosis according to the DSM-IV TR Symptom and Criterion checklist for ASD
• Significant level of repetitive behaviors to distinguish from movement disorders to be in at least 3 out of 6 sub-scales (stereotyped behavior, self-injurious behavior, compulsive behavior, ritualistic behavior, sameness behavior, restricted behavior) -

You may not qualify if:

• Women of child-bearing potential not using birth control, pregnant or breast feeding
• H/o Bipolar Disorder (lifetime), any Psychotic Disorder (lifetime) history of Major Depressive Disorder or of substance abuse or dependence within the past year
• Significant sub-average intellectual function (IQ\<70)
• Intracranial implants
• Increased risk of seizure for any reason, including prior diagnosis of epilepsy, seizure disorder, febrile seizure, increased intracranial pressure or history of significant head trauma with loss of consciousness for \> 5 minutes.
• Current significant laboratory abnormality
• Neurological disorder including but not limited to space occupying brain lesion, any history of seizures, history of cerebrovascular accident, fainting, cerebral aneurysm, dementia, Huntington chorea, Multiple Sclerosis -

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute, 1051 Riverside Drive

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Asperger Syndrome

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Alexandra Sporn, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: November 13, 2013
• Study Start: November 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 24, 2017

Record last verified: 2017-01

Locations

US (1)