| CTRI Number |
CTRI/2025/05/087501 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Transcranial Magnetic Stimulation] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
New non-invasive treatment (Deep Transcranial Magnetic Stimulation) for forgetfulness-like mild cognitive impairment. |
|
Scientific Title of Study
|
Deep Transcranial Magnetic Stimulation (dTMS) for Mild Cognitive Impairment: A Proof of Concept Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Paresh K Doshi |
| Designation |
Director of Restorative and Regenerative Medicine |
| Affiliation |
Jaslok Hospital and Research Center, Mumbai |
| Address |
Department of Restorative and Regenerative Medicine, 7th Floor South, Jaslok Hospital and Research Centre, 15, Dr. G. Deskhmukh Marg, Mumbai - 400026
15 Dr. G Deshmukh Marg, Mumbai, Maharashtra-400026
Mumbai
MAHARASHTRA
400026
India |
| Phone |
9137220165 |
| Fax |
|
| Email |
pareshkd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Paresh K Doshi |
| Designation |
Director of Restorative and Regenerative Medicine |
| Affiliation |
Jaslok Hospital and Research Center, Mumbai |
| Address |
Department of Restorative and Regenerative Medicine, 7th Floor South, Jaslok Hospital and Research Centre, 15, Dr. G. Deskhmukh Marg, Mumbai - 400026
15 Dr. G Deshmukh Marg, Mumbai, Maharashtra-400026
Mumbai
MAHARASHTRA
400026
India |
| Phone |
9137220165 |
| Fax |
|
| Email |
pareshkd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Paresh K Doshi |
| Designation |
Director of Restorative and Regenerative Medicine |
| Affiliation |
Jaslok Hospital and Research Center, Mumbai |
| Address |
Department of Restorative and Regenerative Medicine, 7th Floor South, Jaslok Hospital and Research Centre, 15, Dr. G. Deskhmukh Marg, Mumbai - 400026
15 Dr. G Deshmukh Marg, Mumbai, Maharashtra-400026
Mumbai
MAHARASHTRA
400026
India |
| Phone |
9137220165 |
| Fax |
|
| Email |
pareshkd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jaslok Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Jaslok Hospital and Research Centre |
| Address |
15, Dr. G Deshmukh Marg, Mumbai-400026, Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Dr Paresh K Doshi |
Jaslok Hospital and Research Centre |
Department of Restorative and Regenerative Medicine, 7th Floor South, Jaslok Hospital and Research Centre, 15, Dr. G. Deskhmukh Marg, Mumbai - 400026
Mumbai
MAHARASHTRA |
9137220165
pareshkd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jaslok Hospital and Research Centre |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G31||Other degenerative diseases of nervous system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Deep Transcranial Magnetic Stimulation |
The H7 coil will be used to stimulate the bilateral deep frontal regions of the brain using the Brainsway™ dTMS machine. The surface anatomy of the Left Primary Motor Cortex will be identified. The Left M1 will be stimulated at 60% of the machine’s stimulation output in single pulses spaced 5 seconds to elicit the involuntary contraction of the Right Extensor Hallucis Longus. The pulse stimulation will then be gradually decreased to identify the Motor Threshold (MT) of the patient. The lowest intensity at which stimulation elicits a motor response 3 out of 6 times will be recorded as the MT for the rest of the study. Then, the coil will be moved 6 cm forward from the Left MI to align it with the prefrontal cortex. To train the patient for stimulation, impulses of 100-120% intensity of the MT will be delivered in increments of 10% of MT at a 10Hz frequency. Once the patient is trained, the treatment protocol will be started. During each of the 20 treatment sessions, 42 trains of 10 Hz will be given for 2 seconds every 20 seconds. The total duration of each sitting will be 20 minutes. The 20 sessions will be scheduled at a 1-day gap each. |
| Comparator Agent |
Sham |
The control group will receive a sham intervention with identical parameters, devices, and helmets. However, when the sham mode is initiated, the active H7 coil will be disabled, and a second coil (sham H7 coil) located within the treatment helmet but far above the participant’s scalp will be activated. This sham H7 coil will deliver a tactile and auditory sensation similar to the active H7 coil, but the electric field does not induce neuronal activation.
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Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
- The patient must have at least 6 years of education and be able to read, write, and fully understand the language of the cognitive tests (Here, English).
- The patient must have a Clinical Dementia Rating (CDR) score of 0.5 and a CDR-memory score of equal to or more than 0.5.
- The patient must have a Delayed Recall score of less than or equal to 10 on the New York University (NYU) Paragraph Recall test.
- The patient must have sufficient visual, hearing, and communication ability with or without external aids.
- The patient must also have a consistent informant to accompany them to scheduled study visits.
- The patient must be fit for dTMS as per BRAINSway guidelines. |
|
| ExclusionCriteria |
| Details |
- The patient must not have shortness of breath while sitting.
- The patient will be excluded if the investigator determines that the patient is at risk because of participation in the trial or has a physical condition that may influence the results of the trial.
- The patient must not have a pacemaker or other metallic implant that is unsafe for TMS. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Montreal Cognitive Assessment (MoCA) |
Just after treatment, 1 month after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Dementia Rating Scale (CDR) |
Just after treatment, 1 month after treatment |
| Alzheimer’s Disease Assessment Scale - Cognitive subscale, adapted for use in MCI (ADAS-cog/MCI) |
Just after treatment, 1 month after treatment |
| Alzheimer’s Disease Cooperative Study Activities of Daily Living Adapted to MCI (ADCS-ADL/MCI) |
Just after treatment, 1 month after treatment |
| Delayed Recall Score of the NYU Paragraph Recall Test |
Just after treatment, 1 month after treatment |
| Addenbrooke Cognitive Examination (ACE) |
Just after treatment, 1 month after treatment |
| Adverse Effects |
During and after treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/06/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Introduction - Minor Neurocognitive Disorder (mNCD), formerly known as Mild Cognitive Impairment (MCI), refers to supra-physiological cognitive decline that affects the quality of life but not enough to be classified as Dementia. In line with the limited understanding of the disease, the treatment alternatives are also limited, with only a handful of alternatives showing some promise in preserving cognition. Recently, non-invasive neuromodulation has been explored for its potential benefit in MCI. Stimulation of the dorsolateral prefrontal cortex by repetitive Transcranial Magnetic Stimulation (rTMS) has been found to improve cognitive function. However, the currently available figure-8 coil rTMS systems have limited the application of TMS in MCI due to low penetration. Roth et al. reported that the H-coil directly stimulates the lateral and medial regions of the PFC at depths of up to 3 cm using low power, effectively addressing the depth restrictions associated with conventional rTMS that employ figure-8 coils. Here, we aim to systematically evaluate the efficacy and safety of Deep TMS (dTMS) in patients with MCI.
Methodology - Patients with Mild Cognitive Impairment (MCI) as per DSM-5, eligible for dTMS (based on Brainsway™ guidelines), will be approached to participate in the study. After enrollment in the study, the demographics, clinical history, and cognitive function will be assessed. Cognitive function of the patient will be assessed using MoCA, Clinical Dementia Rating Scale (CDR), Alzheimer’s Disease Assessment Scale - Cognitive subscale, adapted for use in MCI (ADAS-cog/MCI), Alzheimer’s Disease Cooperative Study Activities of Daily Living adapted to MCI (ADCS-ADL/MCI), Delayed Recall Score of the NYU Paragraph Recall Test, and Addenbrooke Cognitive Examination (ACE). Participants will then be randomized into two groups: dTMS and sham-control. The dTMS group will receive 20 sessions of TMS with a Brainsway™ H7 coil, while the sham-controlled group will undergo a dummy paradigm resembling the treatment protocol using the H7 coil. At the end of the treatment, cognitive ability will be assessed again.
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