Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) as an Adjunct to AI Enabled Remedial Intervention in School Going Children (Aged 6-18 Years) Having Specific Learning Disorder With Dyslexia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improvement in reading abilities of the participants as assessed by GLAD scores at 6 and 12 weeks from baseline.
研究概览
简要总结
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.
详细描述
- Consecutive School going children fulfilling DSM V criteria for SLD with dyslexia will be screened in the study centre for eligibility.
- After applying inclusion and exclusion criteria, legal guardians of the participants will be counselled and written informed consent will be taken.
- Baseline data of the participants will be collected.
- GLAD (Grade level Assessment Device Tool ), CTOPP-2 (Comprehensive Test Of Phonological Processing Tool, 2nd edition), WRAT-5 (Wide Range achievement test, 5th edition ) will be administered on the participants at baseline.
- fMRI at baseline will be done for 10 sequential participants whose legal guardians are willing to give consent for the same.
- Intervention Study group will be subjected to 6 weeks of AI enabled remedial education with Hf-rTMS (high frequency - repetitive Transcranial Magnetic stimulation) as per protocol developed based on previous studies of rTMS in SLD and from experience from other studies using rTMS for other indications.
- Participant will be started on AI enabled remediation therapy as described below and after ensuring 1st session of remediation the participant will be called for the rTMS session as detailed below.
AI enabled remedial intervention -
- It will be administered via a Web application based phonological training program (web application address : http://readable.com). This program was Developed at AIIMS, New Delhi (Dept of Pediatrics, Child Neurology division) in collaboration with Delhi IIT, as part of preliminary work done under Dyslexia program under Child Neurology, AIIMS by Dr Sachendra Badal in 2019 (Chief guide ; Professor Sheffali Gulati). This was further adapted to enhance learning by AI technique as part of research work by Dr Sayoni Roy Chowdhary in 2021 (Chief guide; Professor Sheffali Gulati).
- It is a cloud-based application design, which uses a bottom-up strategic learning approach. It was developed for Indian context based on Components of effective remedial program as recommended internationally. It is based on the principle of reinforcement learning with primary focus on phonic awareness, phonics and sight word recognition.
- Structure and Duration - It consists of introductory teaching session which would be administered by the primary investigator for teaching 8 modules over 5 classes (32 hours each) over 1st 10 days using online platform. This would be followed by AI based structured remediation under parental supervision for 1 hr/day, 7 days/week for total 6 weeks . A total of 8 modules would be taught through the AI enabled program.
- Follow up would be done at set intervals after intensive training for 10 days: weekly for two weeks and subsequently fortnightly for rest of duration to ensure proper use of intervention by the primary investigator using telephonic calls to check for compliance. Total number of online sessions, total count of attempted words and total count of correctly pronounced words would be monitored by the web application. Compliance will be defined by (total 52 hours of intervention) Good: > 80% i.e. > 42 hours of intervention; Average: 60-80% i.e. 31-42 hours of intervention; Poor: <60% i.e. < 31 hours of intervention.
rTMS procedure
- Handedness will be determined via Edinburgh handedness inventory - Laterality Index
- Electromyography will be recorded with surface electrodes from the right Abductor pollicis brevis (APB) using a belly tendon montage on the dominant hand
- A figure of eight TMS coil connected to stimulator coil will be placed over the contralateral motor cortex tangentially to the scalp with the handle pointing backward. The motor hot-spot will determined as the location on the scalp where TMS produced the largest MEP from the APB at rest
- Obtaining Motor Cortex Threshold- Lowest stimulator output over the motor hot-spot that could elicit EMG response in APB in 5 out of 10 trials
- Prior to start of each cycle, on day 1 cortical excitability parameters will be recorded using standard protocols for RMT (Resting Motor Threshold), MEP (Motor Evoked Potential), LICI (Long interval intracortical inhibition) and SICI (Short interval intracortical inhibition).
- Site of rTMS - established using 10-20 EEG system at Left IPL (inferior parietal lobule , corresponding to angular and supramarginal gyrus), and left STG (superior temporal gyrus) at P3 and P5 respectively,
- TMS Protocol used for each session - 5 Hz High frequency rTMS, at 100% RMT, 60 pulses per train, total 10 trains , gap between 2 consecutive trains of 30 sec
- Duration - Total 3 cycles per participant will be administered.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.
- Participants will be monitored for adverse events during and after the study period. Appropriate measures such as immediate supine placement upon symptoms or signs of hypotension, intranasal midazolam in case or seizures will be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Primary Outcome measures (GLAD, CTOPP2, WRAT-5) will be assessed by a clinical psychologist not involved in the study
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Improvement in reading abilities of the participants as assessed by GLAD scores at 6 and 12 weeks from baseline.
时间窗: From baseline to 6 and 12 weeks
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.
Improvement in reading abilities of the participants as assessed by CTOPP-2 scores at 6 and 12 weeks from baseline.
时间窗: From baseline to 6 and 12 weeks
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.
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).
时间窗: From baseline to 6 weeks
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.
Improvement in reading abilities of the participants as assessed by WRAT-5 scores at 6 and 12 weeks from baseline.
时间窗: From baseline to 6 and 12 weeks
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.
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).
时间窗: From baseline to 6 weeks
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.
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).
时间窗: From baseline to 6 weeks
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.
次要结局
- 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 describe subjective improvement as assessed by parents and teachers of children with dyslexia(at 6 weeks, 12 weeks and 24 weeks from baseline)
- To describe adverse events noted during Hf rTMS(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 CTOPP-2 scores(From baseline to 24 weeks from 12 weeks and)
- To evaluate the cortical excitability parameter - RMT pre and post intervention(at 6 weeks, 12 weeks and 24 weeks into the study)
- To evaluate the resting state functional networks and brain activation profile during phonological tasks using functional MRI in dyslexic children pre and post intervention(from baseline at 12 weeks (at end of intervention))
- 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)
研究者
Sheffali Gulati
Professor
All India Institute of Medical Sciences, New Delhi