| CTRI Number |
CTRI/2025/12/099053 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of cognitive training on subjective cognitive decline in individuals with migraine |
|
Scientific Title of Study
|
Effectiveness of cognitive intervention on subjective cognitive decline in patients with migraine on psychophysiological outcomes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchika Kalra |
| Designation |
PhD Scholar |
| Affiliation |
Department of Physiotherapy, Amity Institute of health and allied sciences |
| Address |
Room no 5 F1 block lower ground floor Department of Physiotherapy Amity Institute of Health Allied Sciences
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9718417185 |
| Fax |
|
| Email |
kalraruchika123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meena Gupta |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiotherapy, Amity Institute of health and allied sciences |
| Address |
Room no 5 F1 block lower ground floor Department of Physiotherapy Amity Institute of Health Allied Sciences
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9717281491 |
| Fax |
|
| Email |
mgupta9@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Nandwani |
| Designation |
Consultant neurologist |
| Affiliation |
Fortis Hospital Shalimar Bagh |
| Address |
Room no 19 OPD ground floor Fortis Hospital AA-299 Shaheed Udham Singh Marg Shalimar Bagh New Delhi
North West
DELHI
110088
India |
| Phone |
9911475020 |
| Fax |
|
| Email |
saurabhnandwani24@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ruchika Kalra |
| Address |
Room no 5 F1 block lower ground floor Department of Physiotherapy Amity Institute of Health Allied Sciences Amity Univeristy Noida Uttar Pradesh 201301 |
| 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 Meena Gupta |
Amity physiotherapy out patient department |
Room no. 1 Amity physiotherapy OPD
Gautam Buddha Nagar
UTTAR PRADESH |
9717281491
mgupta9@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G988||Other disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Relaxation and Cognitive training |
Relaxation exercises + Cognitive training
Type: Relaxation
Intensity: 5 second hold for every muscle relaxation and pause for 10 seconds.
Frequency: 3 times a week for 6 weeks
Time: 15 minutes
Cognitive intervention yet to be developed
3 times a week for 6 weeks
|
| Comparator Agent |
Relaxation exercises |
Relaxation exercises
Type: Relaxation
Intensity: 5 second hold for every muscle relaxation and pause for 10 seconds.
Frequency: 3 times a week for 6 weeks
Time: 15 minutes
3 times a week for 6 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patient with at least a 1-year history of migraine.
Patient with minimum of 4 attacks in the past 3 months
Diagnosed case of migraine without aura.(Criteria according to ICHD 3 for migraine without aura)
Patient willing to provide the consent.
Patient stating self- subjective cognitive decline with a minimum score of 5 on SCDQ.
|
|
| ExclusionCriteria |
| Details |
Other cases of headache and migraine (Tension, cluster, cervicogenic)
Patients with any endocrine disorders.
Women with pregnancy
Patient with any other type of neurological conditions.
Subject who is already taking such kind of intervention in last 3 months
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Electroencephalography
Subjective cognitive decline questionnaire
Depression, anxiety and stress scale -21
Frontal Battery assessment: |
Pre and Post analysis after 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Migraine-Specific Quality of Life Questionnaire (MSQ) version 2.1
Migraine disability Scale (MIDAS) |
After 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
02/01/2026 |
| 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="3"
Days="2" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ruchika.kalra2@s.amity.edu].
- For how long will this data be available start date provided 12-02-2026 and end date provided 01-01-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Not applicable
|
|
Brief Summary
|
According to WHO, Migraine is a primary headache disorder, in most cases episodic, that usually lasts 4–72 hours, accompanied by nausea, vomiting and/or photophobia and phonophobia. It is sometimes preceded by a short-lasting aura of unilateral, reversable visual, sensory or other symptoms. Migraine is a complex neurological condition with a genetic basis, marked by recurring episodes of moderate to severe headaches. These headaches are often localized to one side of the head and are commonly associated with nausea, as well as increased sensitivity to light and sound. Subjective cognitive decline (SCD) refers to self-perceived worsening of cognitive abilities, such as memory and attention, without objective evidence from cognitive testing. In individuals with migraine, SCD is notably prevalent and appears to be closely linked with comorbid conditions like depression, anxiety, and poor sleep quality. A comparative study design is proposed to be conducted in subjective cognitive decline in patients with migraine. Individuals with clinically diagnosed migraine without aura (ICHD-3), more than 4 attacks over the past 3 months, more than 1-year migraine history, SCD-Q score more than 5, excluding other headache types, neurological/endocrine conditions, pregnancy, or recent cognitive training. Ethical clearance will be obtained from Institutional ethical committee before commencing the project. After receiving the informed consent form, the subjects will be screened for subjective cognitive decline. The screened patients will be allocated in 3 groups: Each group will be for 3 times per week for 6 weeks. |