| CTRI Number |
CTRI/2023/12/060976 [Registered on: 29/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of a brain stimulation technique on activity of brain regions in people with mild cognitive impairment.
The purpose of this study is to test a new brain stimulation technique for improving memory problems in people with mild cognitive impairment. |
|
Scientific Title of Study
|
Effect of transcranial theta-gamma stimulation technique on default mode network activity and connectivity in individuals with mild cognitive impairment: A pilot randomized placebo-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 |
Shivani Mhaskar |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9967942974 |
| Fax |
|
| Email |
shivani7.mhaskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Divya Adhia |
| Designation |
Assistant Professor-Senior scale |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
adhia.divya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Mhaskar |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India
KARNATAKA
576104
India |
| Phone |
9967942974 |
| Fax |
|
| Email |
shivani7.mhaskar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India |
|
|
Primary Sponsor
|
| Name |
Shivani Mhaskar |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal, Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 Manikandan Natarajan |
Kasturba Hospital |
Neuromotor Control Room 3rd floor CTC block Kasturba Hospital Manipal 576104
Udupi
KARNATAKA |
9886898064
mani.kandan@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G30-G32||Other degenerative diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham stimulation |
Actisham protocol developed by Neuroelectrics will be used to create the same skin sensation as the active stimulation. The total duration of the Actisham protocol will be a single session of 30 minutes. A 60s ramp up and 60s ramp down current will be applied at the beginning of the stimulation session and no current will be applied for the remainder of the session but only EEG will be recorded. Thus the sham session duration will thus be equivalent to the active stimulation phase session and will help blind the participants appropriately for the treatment procedure. |
| Intervention |
Transcranial electrical stimulation. |
The transcranial theta-gamma noise stimulation targeting posterior cingulate cortex and parahippocampus will be delivered for a single session of 30 min continuously by a researcher experienced in neuromodulation techniques. A 60s ramping up current and similarly a 60s ramping down current will be used at the start and the end of each treatment session respectively. The gamma noise stimulation will be overlaid on the theta sinusoidal waveform. The total duration of the intervention will be 30 mintues. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. English or Kannada speaking
2. Subjective memory complaints
3. 0.5 score on Clinical Dementia Rating
4. 18-25 score on Montreal Cognitive assessment
5. Preserved daily functions
6. Without symptoms of Dementia
7. Presence of a care-taker for reporting of memory problems of the participant. |
|
| ExclusionCriteria |
| Details |
1. Cognitive decline due to causes or conditions other than amnestic mild cognitive impairment
2.Enrolment in other tentative drug or trial study during the period of trial
3.History of seizures or epilepsy or other neurological disorders
4. Migraine or vertigo
5.Dizziness or balance disorders
6. Any other psychiatric conditions like schizophrenia or bipolar disorders or personality disorders or major depressive disorders
7. Substance abuse disorders
8.Cardiac pacemakers or metal implants in head and neck regions |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Feasibility measures:
-Recruitment rate
-Drop-out rates
-Acceptibility of the intervention
- Safety of the intervention using Adverse Effects Questionnaire
2.Resting state EEG
|
1. Before intervention
2.Immediately after intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Montreal Cognitive Assessment
2.Trail Making Test A and B
3. Pattern Recognition Memory |
1. Before intervention
2. Immediately after intervention |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2024 |
| 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="1"
Months="0"
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
|
Alzheimer’s
Disease (AD), most commonest form of Dementia, which is a substantial worldwide
problem and a growing health challenge. People
with amnestic mild cognitive impairment (MCI) are more likely to progress to AD (10-15% per year), when
compared to normal older people (1-3% per year). Treatments targeted at the MCI stage could thus
potentially prevent or delay the transitions to the AD. Dysfunctional
connectivity in resting state brain networks has been shown by a number of
functional brain imaging studies in people with AD, that are predictive of
progression from MCI to AD. Particularly, structural
and functional alterations in posterior cingulate cortex (PCC) and parahippocampus (PHC) have been demonstrated very early in
AD and are associated with cognitive dysfunctions. The individuals with
progressive MCI demonstrates reduction in the theta–gamma cross frequency coupling when compared to
individuals with stable MCI. Thus specifically targeted
interventions focusing on increasing the functional connectivity and the theta-gamma cross-frequency- coupling between the PCC and PHC could likely improve clinical outcomes, with
greater effect.
The primary objectives of this study are to explore the effect of the transcranial theta-gamma noise stimulation technique on the activity, functional connectivity, and the cross-frequency-coupling of the
targeted brain regions (PCC and PHC) in people with mild cognitive impairment, and to determine the feasibility
of the transcranial theta-gamma noise stimulation technique for treatment of mild cognitive impairment. The secondary objective of the study is to determine the
estimates of changes in the cognitive outcomes following targeted transcranial
theta-gamma noise stimulation technique in people with MCI.
|