| CTRI Number |
CTRI/2024/01/061677 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the effect of Transcranial Direct Current Stimulation and Right Median Nerve Stimulation on Altered level of conscious patients |
|
Scientific Title of Study
|
A comparative study on the effect of Transcranial direct current stimulation and Right median nerve stimulation on patients with Altered level of consciousness: A Randomised clinical trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Raghavendrasingh Dharwadkar |
| Designation |
Assistant profesor |
| Affiliation |
KLE Institute of physiotherapy |
| Address |
Neurology physiotherapy OPD, G-1 Floor, KLE Institute of physiotherapy, medical college campus, J.N, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9886288225 |
| Fax |
|
| Email |
raghavendrasingh@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Raghavendrasingh Dharwadkar |
| Designation |
Assistant profesor |
| Affiliation |
KLE Institute of physiotherapy |
| Address |
Neurology physiotherapy OPD, G-1 Floor, KLE Institute of physiotherapy, medical college campus, J.N, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9886288225 |
| Fax |
|
| Email |
raghavendrasingh@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Neha Raichur |
| Designation |
PG 1st year |
| Affiliation |
KLE Institute of physiotherapy |
| Address |
KLE Institute of physiotherapy, medical college campus, J.N, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9035108070 |
| Fax |
|
| Email |
neharaichur07@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE College of physiotherapy, JN , Medical campus, Nehru Nagar, Belgavi 590010 |
|
|
Primary Sponsor
|
| Name |
KLE College of physiotherapy |
| Address |
KLE College of physiotherapy, medical college campus, JN, Nehru Nagar, Belgaum |
| 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 Raghavendrasingh Dharwadkar |
KLE college of physiotherapy |
KLE college of physiotherapy, JN, Medical Campus, Nehru Nagar, Belgaum
Belgaum
KARNATAKA |
9886288225
raghavendrasingh@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kLE Institute of ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, (2) ICD-10 Condition: R299||Unspecified symptoms and signs involving the nervous and musculoskeletal systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Transcranial direct current stimulation and Right median nerve stimulation |
comparing the effects of transcranial direct current stimulation and right median nerve stimulation on altered level of conscious patients transcranial direct current stimulaion given for 5 days a week for 2 weeks right median nerve stimulation is given for 5 days a week for 2 weeks |
| Intervention |
Transcranial direct current stimulation and Right median nerve stimulation |
comparing the effects of transcranial direct current stimulation and right median nerve stimulation on altered level of conscious patients
transcranial direct current stimulaion given for 5 days a week for 2 weeks
right median nerve stimulation is given for 5 days a week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
GCS score between 8 to 12 with the history of traumatic and nontraumatic brain injury |
|
| ExclusionCriteria |
| Details |
1.Underwent any operative procedures over cranium
2. Severe cardiac arrhythmias or pacemaker implanted
3. Not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GCS scale |
day 1 - day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oromotor functional assessment scale |
day 1- day 10 |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
03/02/2024 |
| 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
|
we are conducting a research on A comparative effects of Transcranial direct current stimulation and Right median nerve stimulation on patients with altered level of consciousness we will be recruiting 20 subjects and will be randomly divided into 2 group of 10 in each group 1 group will be given transcranial direct current stimulation with multimodal sensory stimulation and the 2nd group will be given Right median nerve stimulation with multimodal sensory stimulation the protocol for both the groups is for 5 days a week for 2 weeks |