| CTRI Number |
CTRI/2024/05/066649 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving Thinking Skills in People with Paralysis |
|
Scientific Title of Study
|
"Effect of Anodal transcranial direct current stimulation on attention and executive function in stroke survivors - An experimental 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 |
Dhanashree S Upganlawar |
| Designation |
PG student |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
DR. D. Y. Patil College of Physiotherapy, 3rd floor, Department of
Neurophysiotherapy, Sant Tukaram Nagar, Pimpri.
Pune
MAHARASHTRA
411018
India |
| Phone |
8788660342 |
| Fax |
|
| Email |
upganlawardhanashree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Khandare |
| Designation |
Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
DR. D. Y. Patil College of Physiotherapy, 3rd floor, Department of
Neurophysiotherapy, Sant Tukaram Nagar, Pimpri.
Pune
MAHARASHTRA
411018
India |
| Phone |
8149853651 |
| Fax |
|
| Email |
shilpa.khandare@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Khandare |
| Designation |
Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
DR. D. Y. Patil College of Physiotherapy, 3rd floor, Department of
Neurophysiotherapy, Sant Tukaram Nagar, Pimpri.
Pune
MAHARASHTRA
411018
India |
| Phone |
8149853651 |
| Fax |
|
| Email |
shilpa.khandare@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil college of Physiotherapy, Pimpri, Pune-411018 |
|
|
Primary Sponsor
|
| Name |
Dhanashree S Upganlawar |
| Address |
DR. D. Y. Patil College of Physiotherapy, 3rd floor, Department of
Neurophysiotherapy, Sant Tukaram Nagar, Pimpri. |
| 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 Dhanashree S Upganlawar |
Dr. D Y Patil College Of Physiotherapy,Pune |
DR. D. Y. Patil College
of Physiotherapy, 3rd
floor, Department of
Neurophysiotherapy,
Sant Tukaram Nagar,
Pimpri, Pune. 411018
Pune
MAHARASHTRA |
8788660342
upganlawardhanashree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr. D. Y. Patil college of Physiotherapy, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Transcranial Direct Current Stimulation (tDCS) with cognitive training |
 Transcranial Direct Current Stimulation (tDCS)
1. Informed consent will be to taken from patients.
2. The whole procedure will be explained to the patients.
3. Patients will be comfortably made to sit on the chair.
4. Thoroughly inspect the subject’s scalp for signs of skin lesions, cuts, signs of inflammation or other cutaneous abnormalities.
5. Localize the stimulation target regions on the subject’s head by using an international 10-20 ECG.
6. Mark the point on the subject’s scalp that corresponds to the target locations.
7. The rubber electrode has to be placed on the target location: anode on DLPFC and cathode on the right supraorbital to complete the circuit.
8. Switched on the device before placing the electrode to avoid a sudden surge of the current.
9. The distance between the two electrodes should be 7cm (3 fingers gap).
10. The intensity and duration of the treatment should be 2.0 mA and 20 minutes respectively.
11. After the session is over remove the electrode and then switch off the machine. Clean the area and inspect the area for any changes in the skin.
12. The treatment is scheduled for 1 session per day for 5 days a week over a span of 1 month.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Acute stroke patients.
2. Both genders.
3. MoCA score between 15-25 (mild to moderate cognition)
|
|
| ExclusionCriteria |
| Details |
1. Subjects having metal implants within the skull.
2. Hemodynamically unstable patients.
3. Uncooperative patients or patients not willing to participate.
4. Preceding epilepsy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Stroop test
2. Trail Making Test (TMT)
|
1. baseline at 1st week
2. at the end of 4th week.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Montreal Cognitive Assessment (MoCA) |
1. baseline at 1st week
2. at the end of 4th week |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
Modification(s)
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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="0"
Months="6"
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
|
After a stroke, cognitive impairment significantly increases disability. Working memory and executive function deficiencies are particularly prevalent, chronic, and strongly related to restrictions in daily living tasks. The executive control, default mode network, and salience network are among the functional brain networks hypothesized to be affected locally and globally by post-stroke executive dysfunction.Cognitive areas including spatial awareness, attention, vision, memory, language, and executive function can all be impacted by alterations in the brain. Physical therapy is frequently employed in stroke recovery and has been shown to enhance brain plasticity following localized neurological dysfunction. The effectiveness of transcranial direct current stimulation (tDCS) in enhancing executive function in these populations depends on underlying internal mechanisms, including raising cerebral blood flow perfusion, raising cerebral blood flow velocity, lowering -aminobutyric acid (GABA) synaptic activity, raising NMDA receptor function, and modifying synaptic plasticity. As the cognition factor is mostly ignored consequence in stroke survivors, convectional therapy may improve the cognition status. Transcranial direct current stimulation is novice approach and it has been proved effective in enhancing motor functions in stroke population. Therefore in this research we are focusing on the effect of TDCS on impaired cognition particularly on attention and executive function in stroke survivors. Transcranial direct current stimulation (tDCS) is effective in improving cognition but its effect is unclear for specific domain. Therefore, there is a need to study the effect of tDCS on specific domains of cognition such as attention and executive function. The stroke population is primarily impacted in these cognitive areas.
|