tDCS + Social Learning for Autism

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of New Mexico

Disqualifiers: Neurological disorders, Pregnancy, Hospitalization, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to investigate the effects of multiple sessions of transcranial direct current stimulation (tDCS) delivered while participants complete tasks that target social learning with high functioning adults with ASD and/or high traits of ASD. The main question it aims to answer is: What are the effects of multiple sessions of active compared to sham tDCS, with tDCS simultaneously paired with social learning tasks, from employing a within-subject, cross-over randomized controlled trial design? Participants will: * Complete a randomly assigned block of 5 sessions of active and a block of 5 sessions of sham tDCS, with a four-week break occurring between the two blocks. * Complete social learning tasks simultaneously during receipt of tDCS at each session (whether receiving active or sham tDCS). * Complete behavioral, physiological, and electrophysiological testing before and after each block of active or sham tDCS. * Complete a social validity questionnaire after completion of the study.

Research Team

Bill Shuttleworth, Ph.D.

Principal Investigator

University of New Mexico

Eligibility Criteria

This trial is for adults aged 18-35 with Autism Spectrum Disorder who are proficient in English, have good vision and hearing (with or without correction), score at least 85 on the Shipley-2 intelligence test, and are right-handed. They must be diagnosed with autism or ASD via ADOS-2 or score at least 17 on the Autism Quotient.

Inclusion Criteria

I am proficient in English.

I have been diagnosed with autism or am on the autism spectrum.

I am right-handed according to the Edinburgh test.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Active tDCS

Participants undergo 5 sessions of 30 minutes anodal tDCS combined with social learning tasks on consecutive weekdays

1 week

5 visits (in-person)

Break

A four-week break between the active and sham tDCS blocks

4 weeks

Treatment - Sham tDCS

Participants undergo 5 sessions of 30 minutes placebo anodal tDCS combined with social learning tasks on consecutive weekdays

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Anodal tDCS + Social Learning (Device)
• Placebo Anodal tDCS + Social Learning (Behavioral Intervention)

Trial Overview The study tests if brain stimulation (tDCS) paired with social learning tasks can help adults with ASD. Participants will undergo two blocks of five sessions each: one block using active tDCS and another using sham (placebo) tDCS, separated by a four-week break. Their behavior, physiology, and brain activity will be measured before and after each block.

Participant Groups

Group I: Anodal tDCS + Social Learning Experimental Treatment 1 Intervention

In this arm, participants will undergo 5 sessions of 30 minutes anodal tDCS combined with social learning tasks on consecutive weekdays.

Group II: Placebo anodal tDCS + Social Learning Placebo Group 1 Intervention

In this arm, participants will undergo 5 sessions of 30 minutes placebo anodal tDCS combined with social learning tasks on consecutive weekdays.

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Lisa Kuuttila

University of New Mexico

Chief Executive Officer since 2013

PhD in Pharmaceutical Sciences

David L. Perkins

University of New Mexico

Chief Medical Officer since 2015

MD, PhD

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+