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Efficacy of rTMS as an Adjunct to AI Enabled Remedial Intervention in Children With Dyslexia

NCT05923645 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-06-28

No results posted yet for this study

Summary

Dyslexia is the most common neurobehavioral disorder affecting children, with prevalence rates ranging from 17.5% to 21%. Studies have shown incomplete response to remediation and behavioural therapies in children with dyslexia. Evidence from neuroimaging studies as well as neuromodulation studies supporting a neurobiological basis of dyslexia is extensive according to which under-activation and poor connectivity in the underlying pathways for language and reading is the primary pathophysiology underlying reading difficulties. Evidence from studies on neuromodulation have shown that by combining remedial intervention with neuromodulation there is a synergistic effect through the mechanism of long term potentiation. In view of the above mentioned our study aims to investigate the role of Hf rTMS as an adjunct to AI enabled remedial intervention in children with dyslexia in improving their reading abilities.

Conditions

  • Dyslexia
  • Specific Learning Disability
  • Transcranial Magnetic Stimulation

Interventions

DEVICE

Transcranial magnetic stimulation (Hf rTMS)

TMS protocol - 5 Hz High frequency rTMS, at 100% RMT, 60 pulses per train, total 10 trains , gap between 2 consecutive trains of 30 sec, at left IPL and left STG localised using 10-20 EEG based system at P3 and P5 respectively , using figure of 8 coil 1st cycle of 10 sessions over 10 consecutive days, 2nd cycle of 5 sessions over 5 consecutive days , 3rd cycle for 5 sessions over 5 consecutive days ; gap of 6 weeks between 2 consecutive cycles Total 3 cycles per patient

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Sheffali Gulati · All India Institute of Medical Sciences, New Delh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05923645 on ClinicalTrials.gov