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

NCT05923645 | Unknown DMC

• 1 other identifier: IECPG-758/30.11.2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dyslexia; SLD; TMS; Hf rTMS

Outcome Measures

Primary Outcomes (6)

• Improvement in reading abilities of the participants as assessed by CTOPP-2 scores at 6 and 12 weeks from baseline.

  Difference in mean of CTOPP-2 scores at 6 and 12 weeks from baseline. CTOPP-2 - Comprehensive Test Of Phonological Processing Tool, 2nd edition -tool has been explained in the study description section above.

  From baseline to 6 and 12 weeks

• Improvement in reading abilities of the participants as assessed by GLAD scores at 6 and 12 weeks from baseline.

  Difference in mean of GLAD scores at 6 and 12 weeks from baseline. GLAD - Grade level Assessment Device Tool The tool has been explained in the study description section above.

  From baseline to 6 and 12 weeks

• Improvement in reading abilities of the participants as assessed by WRAT-5 scores at 6 and 12 weeks from baseline.

  Difference in mean of WRAT5 scores at 6 and 12 weeks from baseline. WRAT-5 - Wide Range achievement test, 5th edition The tool has been explained in the study description section above.

  From baseline to 6 and 12 weeks

• Improvement in reading abilities of the intervention group (who received Hf-rTMS with AI based remedial intervention) as assessed by CTOPP-2 scores at 6 weeks as compared to controls (who received only AI based remedial intervention).

  Difference in mean of change in CTOPP-2 scores at 6 weeks between the intervention group and the retrospective data of controls CTOPP-2 - Comprehensive Test Of Phonological Processing Tool, 2nd edition The tool has been explained in the study description section above.

  From baseline to 6 weeks

• Improvement in reading abilities of the intervention group (who received Hf-rTMS with AI based remedial intervention) as assessed by GLAD scores at 6 weeks as compared to controls (who received only AI based remedial intervention).

  Difference in mean of change in GLAD scores at 6 weeks between the intervention group and the retrospective data of controls GLAD - Grade level Assessment Device Tool The tool has been explained in the study description section above.

  From baseline to 6 weeks

• Improvement in reading abilities of the intervention group (who received Hf-rTMS with AI based remedial intervention) as assessed by WRAT5 scores at 6 weeks as compared to controls (who received only AI based remedial intervention).

  Difference in mean of change in WRAT5 scores at 6 weeks between the intervention group and the retrospective data of controls WRAT-5 - Wide Range achievement test, 5th edition The tool has been explained in the study description section above.

  From baseline to 6 weeks

Secondary Outcomes (9)

• To compare the domain wise change CTOPP-2 scores of participants pre and post intervention

  From baseline to 6 and 12 weeks

• To compare the domain wise change WRAT-5 scores of participants pre and post intervention

  From baseline to 6 and 12 weeks

• To evaluate the persistence of effect of Hf rTMS in children with dyslexia at 24 weeks as assessed by WRAT5 scores

  From baseline to 24 weeks from 12 weeks and

• To evaluate the persistence of effect of Hf rTMS in children with dyslexia at 24 weeks as assessed by GLAD scores

  From baseline to 24 weeks from 12 weeks and

• To evaluate the persistence of effect of Hf rTMS in children with dyslexia at 24 weeks as assessed by CTOPP-2 scores

  From baseline to 24 weeks from 12 weeks and

Study Arms (1)

High frequency repetitive Transcranial Magnetic Stimulation

EXPERIMENTAL

Children who have given consent for the study and are fulfilling the inclusion and exclusion criteria will be enrolled and given Transcranial magnetic stimulation (TMS) as per protocol as described below over 12 week along with AI based remedial intervention. 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

Device: Transcranial magnetic stimulation (Hf rTMS)

Interventions

Transcranial magnetic stimulation (Hf rTMS) DEVICE

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

Also known as: AI based remedial intervention

High frequency repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Indian school going children aged 6-18 years having specific learning disorder (SLD) with dyslexia diagnosed by DSM-5 criteria
• English as one of the languages in school
• Parents willing for the study

You may not qualify if:

• Parents not willing to participate or follow up at desired frequency of study
• Child who has already received or is on remedial intervention within last 12 weeks provided by Child Psychologist/ Clinician/Psychiatrist
• Children who participated in a completed DM dissertation on remedial program in SLD
• Child already on any psychotropic medications
• Neurological or psychiatric disorder other than comorbid disorders of SLD
• Uncontrolled epilepsy as defined by seizure frequency \>1/month for preceding 3 months
• Severe concurrent illness or disease or unstable medical conditions
• Any contraindications for MRI like presence of pacemaker, metallic implant
• Any contraindications for TMS like Implanted electronic device and non-removable metallic objects near coil e.g. pacemaker, cochlear implant; presence of ferromagnetic metal in the head outside the mouth; on medication lowering seizure threshold.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Dyslexia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Sheffali Gulati

  All India Institute of Medical Sciences, New Delh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheffali Gulati

CONTACT

01126594679; sheffaligulati@gmail.com

Sheffali Gulati

CONTACT

9810386847; sheffaligulati1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Primary Outcome measures (GLAD, CTOPP2, WRAT-5) will be assessed by a clinical psychologist not involved in the study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Ambispective Quasi-experimental study design

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: June 28, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)