Evaluation of Theta Burst Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder
NCT06040775, Not applicable, Unknown, All India Institute of Medical Sciences
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of Theta Burst Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder | ClinicalTrials.gov |
| NCT number | NCT06040775 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 82 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | All India Institute of Medical Sciences | ClinicalTrials.gov |
| Conditions | Autism Spectrum Disorder | ClinicalTrials.gov |
| Interventions | Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coil, Sham magnetic stimulation using sham MCF-B65 coil | ClinicalTrials.gov |
| First posted | 2023-09-18 | ClinicalTrials.gov |
| Last updated | 2023-09-26 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in core function deficit in obsessive and repetitive behavior between intervention and control arm | 4 weeks +/- 3 days from end of therapy | Difference in mean change in total Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) and Repetitive Behaviors Scale - Revised (RBS-R) score between intervention and control group CYBOCS- Clinician-report questionnaire, 70 questions, Each on scale of of 0-4, Maximum score -280, minimum score- 0. Higher scores suggest mores severe symptoms RBS-R - Self report/caregiver, 44-item, Each on scale of of 0-4, Maximum score -176, minimum- 0. Higher scores suggest mores severe symptoms | ClinicalTrials.gov |
| Secondary | Change in core function deficit in social behavior and overall autism score between intervention and control arm | 4 weeks +/- 3 days from end of therapy | Difference in mean change in total Social Responsiveness Scale, Second Edition (SRS-2) and Childhood Autism Rating Scale, Second Edition (CARS-2) scores between intervention and control group SRS-2- Parent or teacher questionnaire (65 items on a 4- point Likert scale), Five domain scores ("Treatment Subscales"), Expressed as a raw score or a T-scores. Higher scores more severe social impairment CARS-2 -15 item scale, 1-4 in key areas related to autism diagnosis. For under 12 years of age, scores of 30 or above are indicative of autism and for students 12 years and older, scores of 28 or above are considered to be indicative of autism. | ClinicalTrials.gov |
| Secondary | Change in core function deficit in social behavior and overall autism score between intervention and control arm | 12 weeks +/- 7 days from end of therapy | Difference in mean change in total CY-BOCS, RBS-R, SRS-2, CARS-2 scores between intervention and control group CYBOCS- Clinician-report questionnaire, 70 questions, Each on scale of of 0-4, Maximum score -280, minimum score- 0. Higher scores suggest mores severe symptoms RBS-R - Self report/caregiver, 44-item, Each on scale of of 0-4, Maximum score -176, minimum- 0. Higher scores suggest mores severe symptoms SRS-2- Parent or teacher questionnaire (65 items on a 4- point Likert scale), Five domain scores ("Treatment Subscales"), Expressed as a raw score or a T-scores. Higher scores more severe social impairment CARS-2 -15 item scale, 1-4 in key areas related to autism diagnosis. For under 12 years of age, scores of 30 or above are indicative of autism and for students 12 years and older, scores of 28 or above are considered to be indicative of autism. | ClinicalTrials.gov |
| Secondary | Change in parent reported quality of life as assessed by PedsQL score between intervention and control arm | 4 weeks +/- 3 days from end of therapy and 12 weeks +/- 7 days from end of therapy | Difference in mean change in total Pediatric Quality of Life Inventory (PedsQL) score between intervention and control group | ClinicalTrials.gov |
| Secondary | Describe Adverse events noted in intervention and control arm | 4 weeks +/- 3 days from end of therapy | Adverse event rate defined as ratio of sessions with adverse events divided by total sessions Adverse event will be defines as- positive increase in any of the ROS (review of systems) criteria compared to pre therapy (which will be filled at end of each therapy session) | ClinicalTrials.gov |
| Secondary | To describe effect of TBS in clinical tests for executive function using Wisconsin Card Sorting Test (in study population with IQ>70) | at first visit, at 4 weeks +/- 3 days from end of therapy and at 12 weeks from end of therapy | Wisconsin Card Sorting Test- Mean of change in total error score will be calculated for intervention and control arms | ClinicalTrials.gov |
| Secondary | To describe effect of TBS in clinical tests for executive function using Stroop test time(in study population with IQ>70) | at first visit, at 4 weeks +/- 3 days from end of therapy and at 12 weeks from end of therapy | Stroop test time- Total time to complete 3 paged stroop test (in seconds) will be compared or intervention and control arms | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)