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To evaluate brain activity and eye movements in children and adolescents with ADHD to assess the effect of treatment

To assess prefrontal cortical activity in children and adolescents with ADHD using fNIRS, saccadic eye movements and the effect of treatment: A Randomised Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057306
Enrollment
40
Registered
2023-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F902- Attention-deficit hyperactivity disorder, combined type

Interventions

Intervention1: Methylphenidate: The dose of Methylphenidate will be 10 mg. This is in accordance with the guidelines of the Indian Psychiatric Society and National Institute of Healthcare and Excell

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Cases: 1.Children and adolescents diagnosed with ADHD as per DSM-5. 2.Age: 6-16 years. 3.Gender: Male. 4.Ability to comprehend instructions for testing. 5.Availability of at least 1 parent. 6.Assent from child and informed consent from parent. 7.Treatment naïve children. 8.Subjects that are advised Methylphenidate by the treating clinician. Inclusion Criteria for Controls: 1.Healthy children. 2.Age: 6-16 years. 3.Gender: Male. 4.Ability to comprehend instructions for testing. 5.Availability of at least 1 parent. 6.Assent from child and informed consent from parent.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Cases: 1.History of any major medical illness. 2.History of any other psychiatric disorder (by clinical evaluation). 3.History of an episode of seizure. Exclusion Criteria for Controls: 1.History of any major medical illness. 2.History of any psychiatric disorder (by clinical evaluation). 3.History of an episode of seizure.

Design outcomes

Primary

MeasureTime frame
1. To compare prefrontal cortical activity and saccadic eye movements in children with ADHD to healthy controls. 2. To evaluate the acute effect of Methylphenidate on prefrontal cortical activity during saccadic eye movements in children with ADHD. Timepoint: Initial baseline assessment will be done after comprehensive clinical evaluation. Post intervention assessment will be done 2 hours after the intervention on the same day of baseline assessment.—

Secondary

MeasureTime frame
To compare prefrontal cortical activity with the severity of ADHDTimepoint: Initial baseline assessment will be done after comprehensive clinical evaluation. Post intervention assessment will be done 2 hours after the intervention on the same day of baseline assessment.—

Countries

India

Contacts

Public ContactDr Rajesh Sagar

All India Institute of Medical Sciences

rsagar29@gmail.com9711336435

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026