| CTRI Number |
CTRI/2025/08/093384 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cognitive Rehabilitation] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Music Rhythm-Intervention Targeting Attention Functions in Stroke patients |
|
Scientific Title of Study
|
Music Rhythm-Intervention Targeting Attention in Stroke: A Neuropsychological and Electrophysiological Quasi-randomized 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 |
Shreyas Krishnakumar |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
3rd Floor, Department of Clinical Psychology, MV Govindaswamy Building, NIMHANS, Hosur Road, Bengaluru
Bangalore
KARNATAKA
560078
India |
| Phone |
09445102770 |
| Fax |
|
| Email |
shreyaskrishnakumar72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shantala Hegde |
| Designation |
Additional Professor, Consultant |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
3rd Floor, Department of Clinical Psychology, MV Govindaswamy Building, NIMHANS, Hosur Road, Bengaluru
Bangalore
KARNATAKA
560078
India |
| Phone |
26995183 |
| Fax |
|
| Email |
shantala.hegde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shantala Hegde |
| Designation |
Additional Professor, Consultant |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
3rd Floor, Department of Clinical Psychology, MV Govindaswamy Building, NIMHANS, Hosur Road, Bengaluru
Bangalore
KARNATAKA
560078
India |
| Phone |
26995183 |
| Fax |
|
| Email |
shantala.hegde@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences
Hosur road, Bengaluru, Karnataka, India - 560029 |
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
National institute of Mental Health and Neurosciences, Hosur Road, Bengaluru |
| 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 |
| Dr Shantala Hegde |
National Institute of Mental Health and Neurosciences |
Department of Clinical Psychology,
MV Govindaswamy Building,
NIMHANS, Bengaluru 560029
Bangalore
KARNATAKA |
08026995183
shantala.hegde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal healthy volunteers are comparison group for neurocognitive functions |
| Patients |
(1) ICD-10 Condition: I60-I69||Cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Audiobook/Story listening |
Audiobook/story listening intervention, 15 sessions, 20-30 minutes each session, over 3 weeks, in-patient care. |
| Intervention |
Coherence - rhythm training application |
Rhythm training intervention, 15 sessions, 20-30 minutes each session, over 3 weeks, in-patient care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
First ever anterior circulation stroke confirmed by CT or MRI
Early sub acute period at the time of intervention
Age 18 to 55 years
Ability to read and write at least one language.
Ability to comprehend English Hindi Tamil and Kannada
|
|
| ExclusionCriteria |
| Details |
Co morbid neurological disorders
Global or Receptive aphasia
Hemineglect
Audiovisual impairments
Severe cognitive impairment as measured by a score of 10 or below on MoCA
Medically unstable at the time of recruitment
Unamenable for neuropsychological testing due to reasons not abovementioned
Sub normal pre-morbid intellectual functioning as measured clinically
History of formal music training |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Attention functions as tested on neuropsychological tests and EEG/ERP paradigms |
pre-post intervention. 3-4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Other neurocognitive functions (including executive functions and memory) |
pre-post intervention. 3-4 weeks |
| Functional outcomes |
pre-post intervention. 3-4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/09/2025 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Stroke is a leading cause of long-term disability worldwide, with attention deficits being among the most common and functionally debilitating cognitive impairments. This quasi-randomized study aims to evaluate the efficacy of a rhythm-based intervention in enhancing attention among individuals with stroke. he study will be conducted at NIMHANS, Bengaluru, with stroke participants in the early sub-acute phase (7 days to 3 months post-stroke), aged 18–55 years, with first-ever anterior circulation strokes confirmed by CT/MRI. Age- and education-matched healthy controls will also be recruited. In Phase I, stroke patients will be compared with healthy controls on attention tasks using behavioral and EEG/ERP methods. In Phase II, stroke patients will be assigned to either a rhythm-based intervention group or an active control group (audiobook/story listening), each undergoing 15 sessions over three weeks. Primary outcomes include measurement of various attention domains, measured through computerized tasks and EEG indices. Secondary outcomes include assessment of various neuropsychological functions (including executive functions) and functional outcomes in stroke. Findings are expected to establish rhythm training as a novel, cost-effective adjunct to cognitive rehabilitation in stroke, with potential broader applicability across neurological conditions |