| CTRI Number |
CTRI/2024/03/064496 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Examining the Impact of Intermittent Theta Burst Stimulation on Cognitive Function, Coma Recovery, ICU Mobility, and Hospital Stay Duration in Traumatic Brain Injury: A Comparative study |
|
Scientific Title of Study
|
Effect of intermittent theta burst stimulation on cognition, coma recovery, ICU mobility and length of hospital stay in traumatic brain injury: A comparative 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 |
Bhumala vaidya |
| Designation |
PG student |
| Affiliation |
Ravi Nair Physiotherapy Collage |
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy Collage, Datta Meghe Institute of Higher Education and Research (deemed to be a university), Sawangi (meghe), Wardha.
Department of Neurophysiotherapy, Ravi Nair Physiotherapy Collage, Datta Meghe Institute of Higher Education and Research (deemed to be a university), Sawangi (meghe), Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9764453100 |
| Fax |
|
| Email |
bhumalavaidya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghumahanti Raghuveer |
| Designation |
Professor |
| Affiliation |
Ravi Nair Physiotherapy Collage |
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy Collage, Datta Meghe Institute of Higher Education and Research (deemed to be University), Sawangi (meghe) , Wardha
Department of Neurophysiotherapy, Ravi Nair Physiotherapy Collage, Datta Meghe Institute of Higher Education and Research (deemed to be University), Sawangi (meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8126506769 |
| Fax |
|
| Email |
raghuneuro@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghumahanti Raghuveer |
| Designation |
Professor |
| Affiliation |
Ravi Nair Physiotherapy Collage |
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy Collage, Datta Meghe Institute of Higher Education and Research (deemed to be University), Sawangi (meghe), Wardha
Department of Neurophysiotherapy, Ravi Nair Physiotherapy Collage, Datta Meghe Institute of Higher Education and Research (deemed to be University), Sawangi (meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8126506769 |
| Fax |
|
| Email |
raghuneuro@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(DU), Sawangi (Meghe), Wardha-442004. |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(DU), Sawangi (Meghe), Wardha-442004. |
| 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 Bhumala vaidya |
Acharya vinoba bhave hospital |
Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha-442004.
Wardha
MAHARASHTRA |
9764453100
bhumalavaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of etics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S060||Concussion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intermittent Theta burst stimulation for improved Cognition, coma recovery, ICU mobility and length of hospital stay in traumatic brain injury adjunct to conventional physiotherapy therapy |
The stimulation is provided by a transcranial magnetic stimulation system. The ITBS parameters were based on the standard ITBS protocols, Intermittent patterns of TBS (iTBS; 190 s of stimulation comprised of 3, 50 Hz pulses administered every 200 ms, and each burst repeated every 10 s, with 600 total pulses applied at 80% of a subject’s active motor threshold (AMT)) tend to increase neural excitability. iTBS was found to be effective for increasing MEP amplitudes for up to 30 min.[3] Patients received iTBS sessions at the left dorsolateral prefrontal cortex (left DLPFC) by the repetitive transcranial magnetic stimulation (rTMS) system for 5 consecutive days in a week and underwent clinical evaluation before iTBS and 4 weeks after treatment completion. This group received conventional physiotherapy, i.e. positioning, stretching and passive or active assisted or assisted exercise, twice daily, 5 days a week, for 4 weeks |
| Comparator Agent |
Multimodal stimulation for coma arousal and Conventional physiotherapy therapy |
The intervention group received the sensory stimulation multimodal treatment. Hearing stimulation was given by calling the patient’s name and sharing memories with the patient for five minutes at a distance of 10 cm from both ear canals. The stimulation was provided by the family calling the patient’s name three times, then describing family memories involving the patient until time ran out. Visual stimulation was given for five minutes by showing family photos to the patient at a distance of 10 cm from the eyes; if the patient’s eyes closed, then the nurse helped reopen them. Touch stimulation was given for five minutes, in which family members touched and gently rubbed the patient’s shoulder, then shook and gently rubbed the back of the patient’s hands. Olfactory stimulation was given for five minutes, with the researcher providing aromatic stimulation via the scent typically used by the patient at a distance of three cm from the nostril; specifically, the scent was the patient’s favorite perfume. Gustatory stimulation was given for five minutes, in which researchers applied lemon juice and various other essences/flavourings to a cotton bud that was touched onto the tip of the patient’s tongue Each stimulation lasted for a duration of five minutes so that each sensory stimulation session lasted for 30 minutes. Subjects in control group received conventional physiotherapy, i.e. positioning, stretching and passive or active assisted or assisted exercise, twice daily, 5 days a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
50.00 Day(s) |
| Gender |
Both |
| Details |
1. Subject with traumatic brain injury with Glasgow Coma Scale scores between 9-12.
2. Both male and female genders.
3. Above 20 years–50 years of age.
4. Written informed consent was obtained by the legal representation of patients, who were going to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with a history of epilepsy.
2. Patients who had a history of a metallic implant or peacemaker.
3. skull fractures, craniotomy, craniectomy, and missing tissue.
4. Pregnant females
5. Claustrophobic patients.
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Glasgow Coma Scale.
ICU Mobility Scales.
|
outcome will be assessed at baseline and after 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Galveston Orientation & Amnesia Test.
2. The Functional Independence Measure.
3. The Rancho Los Amigos Scale.
|
outcome will be assessed at baseline & after 4 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
12/04/2024 |
| 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
|
intermittent
theta burst stimulation may produce a more powerful and long-lasting effect on
cortical excitability. However, no studies have explored the efficiency of intermittent
theta burst stimulation in Traumatic
brain injury injury patients with GCS score between 9-12 . Hence, in the present study, we
aimed to perform a systematic evaluation of intermittent theta burst
stimulation efficiency in disease of consciousness, coma recovery, ICU mobility
using multiple electroencephalography markers along with the Glasgow coma Scale |