RECRUITING

Transcranial Magnetic Stimulation (TMS) to Treat Depression in Autism Spectrum Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will assess clinical and behavioral measures along with electroencephalogram (EEG), event-related potentials (ERPS), and eye-tracking (ET) prior to and following a single intermittent Theta Burst Stimulation (iTBS) session to provide preliminary insight into the potential of TMS as an intervention for depression in individuals with Autism Spectrum Disorder (ASD).

Official Title

Neuromodulation for Depression in Autism Spectrum Disorder

Quick Facts

Study Start:2024-04-30

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06142955

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Individuals from Yale University and the surrounding community who are between the ages of 18 and 40 years old with or without a diagnosis of depression. Or individuals between the ages of 18 and 40 years old with a diagnosis of autism spectrum disorder, autistic disorder, PDD NOS, or Asperger syndrome with or without a diagnosis of depression. * A depression score on the HDRS-17 of at least 20 will be used as a cut-off for depression. * Participants are unmedicated or on stable medication treatment for at least two weeks. * Willingness and ability to participate in an EEG and eye-tracking procedure. * Provision of signed and dated informed consent.	* Participants reporting significant head trauma or serious brain illness. * Participants unable to provide signed informed consent. * Participants with major psychiatric illness that would preclude completion of study measures. Participants with diagnosis of a psychotic or bipolar illness with be excluded. * Participants with a history of serious medical illness, stroke, seizures, epileptiform EEG abnormalities, or family history of epilepsy. * Participants taking prescription medications that may affect cognitive processes under study. * Participants taking any medication that may increase their risk of seizures. * Participants who have taken alcohol or recreational drugs within the preceding 24 hours prior to the scheduled study visit as determined by the urine toxicology test. * Participants with a history of substance or alcohol abuse or dependence in the past 6 months. * Participants with a significant risk of suicide or a h/o suicide attempt in the last 6 months. Participants with active suicidal ideation will be excluded from the study. * Females of known/suspected pregnancy or who test positive on a pregnancy test. * Participants with a history of metalworking or injury by shrapnel or metallic objects. * Participants with a history of prior TMS therapy or use of an investigational drug within 12 weeks of visit * Participants with an IQ below 80 (as confirmed by the WASI, Wechsler Abbreviated Scale of Intelligence)

Inclusion Criteria

Exclusion Criteria

* Individuals from Yale University and the surrounding community who are between the ages of 18 and 40 years old with or without a diagnosis of depression. Or individuals between the ages of 18 and 40 years old with a diagnosis of autism spectrum disorder, autistic disorder, PDD NOS, or Asperger syndrome with or without a diagnosis of depression.
* A depression score on the HDRS-17 of at least 20 will be used as a cut-off for depression.
* Participants are unmedicated or on stable medication treatment for at least two weeks.
* Willingness and ability to participate in an EEG and eye-tracking procedure.
* Provision of signed and dated informed consent.

* Participants reporting significant head trauma or serious brain illness.
* Participants unable to provide signed informed consent.
* Participants with major psychiatric illness that would preclude completion of study measures. Participants with diagnosis of a psychotic or bipolar illness with be excluded.
* Participants with a history of serious medical illness, stroke, seizures, epileptiform EEG abnormalities, or family history of epilepsy.
* Participants taking prescription medications that may affect cognitive processes under study.
* Participants taking any medication that may increase their risk of seizures.
* Participants who have taken alcohol or recreational drugs within the preceding 24 hours prior to the scheduled study visit as determined by the urine toxicology test.
* Participants with a history of substance or alcohol abuse or dependence in the past 6 months.
* Participants with a significant risk of suicide or a h/o suicide attempt in the last 6 months. Participants with active suicidal ideation will be excluded from the study.
* Females of known/suspected pregnancy or who test positive on a pregnancy test.
* Participants with a history of metalworking or injury by shrapnel or metallic objects.
* Participants with a history of prior TMS therapy or use of an investigational drug within 12 weeks of visit
* Participants with an IQ below 80 (as confirmed by the WASI, Wechsler Abbreviated Scale of Intelligence)

Contacts and Locations

Study Contact

Sherab Tsheringla, MD

CONTACT

2032158046

sherab.tsheringla@yale.edu

Principal Investigator

Sherab Tsheringla, MD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale Psychiatric Hospital

New Haven, Connecticut, 06520

United States

Collaborators and Investigators

Sponsor: Yale University

Sherab Tsheringla, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-30

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-04-30

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Autism Spectrum Disorder