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CTRI Number  CTRI/2023/07/055814 [Registered on: 28/07/2023] Trial Registered Prospectively
Last Modified On: 31/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study on the therapeutic effects of transcranial magnetic stimulation and transcranial direct current stimulation on improving brain functions in elderly people with cognitive impairment 
Scientific Title of Study
Modification(s)  
Non-invasive brain stimulation for cognitive enhancement in elderly with MCI - a randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Albert Stezin Sunny 
Designation  Scientific Officer Grade I 
Affiliation  Centre for Brain Research, Indian Institute of Science 
Address  Clinical room, Ground floor Centre for Brain Research, Indian Institute of Science, Bangalore-12

Bangalore
KARNATAKA
560012
India 
Phone  8884922557  
Fax    
Email  stezins@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Albert Stezin Sunny 
Designation  Scientific Officer Grade I 
Affiliation  Centre for Brain Research, Indian Institute of Science 
Address  Clinical room, Ground floor Centre for Brain Research, Indian Institute of Science, Bangalore-12

Bangalore
KARNATAKA
560012
India 
Phone  8884922557  
Fax    
Email  stezins@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Albert Stezin Sunny 
Designation  Scientific Officer Grade I 
Affiliation  Centre for Brain Research, Indian Institute of Science 
Address  Clinical room, Ground floor Centre for Brain Research, Indian Institute of Science, Bangalore-12

Bangalore
KARNATAKA
560012
India 
Phone  8884922557  
Fax    
Email  stezins@gmail.com  
 
Source of Monetary or Material Support  
Centre for Brain Research, Indian Institute of Science Campus CV Raman Avenue Bangalore 560012. India. 
 
Primary Sponsor  
Name  Centre for Brain Research 
Address  Centre for Brain Research Indian Institute of Science Campus CV Raman Avenue Bangalore 560012. India. 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Albert Stezin  Centre for Brain Research  Room 1, Clinical and Scientific Staff Division (Ground floor), Department of Clinical Neurosciences, Centre for Brain Research, Indian Institute of Science Campus CV Raman Avenue Bangalore 560012. India
Bangalore
KARNATAKA 
8884922557

stezins@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Centre for Brain Research-Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G308||Other Alzheimers disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Repetitive transcranial magnetic stimulation - theta burst stimulation   Repetitive transcranial magnetic stimulation - theta burst stimulation on left dorsolateral prefrontal cortex for 3 minutes per session for 5 days/week for 3 weeks  
Intervention  Sequential transcranial direct current stimulation and repetitive transcranial magnetic stimulation  Sequential administrations of transcranial direct current stimulation (20 minutes of 1mA on the left dorsolateral prefrontal cortex for 5 days/week for 3 weeks) and repetitive transcranial magnetic stimulation (theta burst stimulation on left dorsolateral prefrontal cortex for 3 minutes per session for 5 days/week for 3 weeks) 
Comparator Agent  Sham   Sham intervention without stimulation 
Intervention  Transcranial direct current stimulation   Transcranial direct current stimulation (tDCS)- 20 minute of 1mA on left dorsolateral prefrontal cortex for 5 days/week for 3 weeks  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Satisfying the Manchester Consensus criteria for Mild cognitive impairment or ICD10 criteria for minor neurocognitive disorder  
 
ExclusionCriteria 
Details  1. No other known neurological or psychiatric disease
2. Presence of metallic implants/pacemaker
3. Present or past history of seizures
4. Use of medicines altering cortical excitability
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Montreal Cognitive Assessment score
Hindi Mental status examination score
Addenbrooke Cognitive Examination III score
 
1 week, 4 week, 12 weeks, & 24 weeks after intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
Telephonic administration of Montreal Cognitive Assessment score & Hindi Mental status examination score, and Addenbrooke Cognitive Examination III score   Every 30th day after the last day of intervention 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Mild Cognitive Impairment (MCI) is a pre-dementia state that has been widely accepted and studied. It is presently understood that interventions in this early stage can prevent the progression to dementia and have been studied by many research groups. Being a transition state between normal aging and dementia which may not always progress to dementia, limited interventions have been tried at this stage. Two interventions that have been previously linked to the improvement of cognition in MCI are transcranial Direct Current Stimulation (tDCS) and repetitive Transcranial Magnetic Stimulation (rTMS). Both of these have been shown by several studies to be effective in improving cognition in elderly people who have MCI. Hence, this research proposal puts forth an exploratory approach to compare the intervention success rates with tDCS and rTMS alone and in combination and duration of the therapeutic effect. For the purpose of analysis, a randomized controlled study is proposed to evaluate the effect of these interventions in MCI. For the proposed study, we plan on recruiting 120 people with MCI. All the participants of this study will be evaluated using global cognitive screening tools such as MoCA, HMSE, and ACE III at the beginning of the study. Then the participants will be randomly allocated to four groups, viz. No intervention, tDCS, rTMS, and sequential intervention with tDCS and RTMS. After completion of a single intervention regimen is completed, all participants will undergo serial assessments using cognitive tests at one week, 4 weeks, 12 weeks, and 24 weeks from the last day of the intervention. From the difference in performance in the cognitive tests, the efficacy of the interventions alone and in combinations, and the duration of effect will be inferred. This research will provide insights contributing to the relevance of tDCS and rTMS as a treatment in older adults with mild cognitive impairment.

 


 
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