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

Phase 4

Not yet recruiting

Conditions: Other Alzheimers disease,

Registration Number: CTRI/2023/07/055814

Lead Sponsor: Centre for Brain Research

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Satisfying the Manchester Consensus criteria for Mild cognitive impairment or ICD10 criteria for minor neurocognitive disorder.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hindi Mental status examination score	1 week, 4 week, 12 weeks, & 24 weeks after intervention
Addenbrooke Cognitive Examination III score	1 week, 4 week, 12 weeks, & 24 weeks after intervention
Montreal Cognitive Assessment score	1 week, 4 week, 12 weeks, & 24 weeks after intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): Centre for Brain Research
🇮🇳
Bangalore, KARNATAKA, India
Centre for Brain Research
🇮🇳Bangalore, KARNATAKA, India
Dr Albert Stezin
Principal investigator
8884922557
stezins@gmail.com