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
|
|
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
|
|
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.
|