| CTRI Number |
CTRI/2024/04/066577 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study to evaluate effect of transcranial magnetic stimulation on independence in daily life in patients with post-op hemiparesis after surgical removal of a brain tumor(mass) |
|
Scientific Title of Study
|
Utility of repetitive transcranial magnetic stimulation on functional outcomes in patients with intracranial mass lesion and postoperative hemiparesis undergoing rehabilitation |
| 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 Anupam Gupta |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Neurological Rehabilitation
National Institute of Mental Health and Neurosciences
Hosur Road
Bengaluru
Karnataka 560029, India
Bangalore KARNATAKA 560029 India |
| Phone |
9480829740 |
| Fax |
|
| Email |
drgupta159@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Merlin V Cherian |
| Designation |
Academic Junior Resident |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Neurological Rehabilitation
National Institute of Mental Health and Neurosciences
Hosur Road
Bengaluru
Karnataka 560029, India
Bangalore KARNATAKA 560029 India |
| Phone |
7034112912 |
| Fax |
|
| Email |
merlinvc18@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anupam Gupta |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Neurological Rehabilitation
National Institute of Mental Health and Neurosciences
Hosur Road
Bengaluru
Karnataka 560029, India
Bangalore KARNATAKA 560029 India |
| Phone |
9480829740 |
| Fax |
|
| Email |
drgupta159@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| There is no external funding for the study. Charges incurred for the trial intervention are waived off by the institution. |
|
|
Primary Sponsor
|
| Name |
The infrastructure for conducting study is provided by NIMHANS Hospital, Bengaluru |
| Address |
NIMHANS Hospital
Hosur Road
Bengaluru 560029 |
| 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 Anupam Gupta |
NIMHANS Hospital, Bengaluru |
ROOM 17, NEURO REHABILITATION WARD, 1ST FLOOR, DEPARTMENT OF NEUROLOGICAL REHABILITATION, NIMHANS, OPPOSITE SBI, HOSUR ROAD Bangalore KARNATAKA |
9480829740
drgupta159@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee NIMHANS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C71||Malignant neoplasm of brain, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Repetitive trancranial magnetic stimulation |
Repetitive transcranial magnetic stimulation (Non Invasive) will be provided using MagVenture MagPro R100 stimulator equipped with a liquid-cooled figure-of-eight coil (each loop 70 mm in diameter). Magnetic stimulation will be applied at 120% of the resting motor threshold (rMT) at 1 Hz frequency. Each session would last for 20 minutes.Individuals in the intervention group will receive a total of 12 rTMS sessions, one session a day,for 5-6days/week excluding general holidays and any other unforeseen circumstances.Patient is expected to remain admitted in the ward for about 2.5weeks. |
| Comparator Agent |
Standard of care in patient rehabilitation programme |
This will consist of cognitive assessment and therapy, physiotherapy, occupational therapy, psychosocial assessment & strategies. All patients will undergo the above sessions for 5 to 6 days a week for a total of 12 sessions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a)Subject is ≥ 18 and ≤ 65 years old at the time of enrollment.
b)Operated patients with intracranial mass lesion presenting with hemiparesis persisting for atleast 1 week following surgical resection of the tumor.
c)Patients with modified Rankin Scale mRS scores between 2-5 at the time of recruitment.
d)Subject or his/her relative has been informed of the nature of the study, can understand the requirements of the study, agrees to participate, and is willing to give an informed consent.
|
|
| ExclusionCriteria |
| Details |
a)Patients with intracranial mass lesion presenting with focal motor deficits preoperatively
b)Contraindications to rTMS, such as presence of metallic implants anywhere in the head, excluding the mouth, individuals with cardiac pacemakers, implanted medication pumps and patients with intracardiac lines.
c)Persons with serious heart disease (CAD, arrythmias, valvular lesions, congenital heart diseases, cardiomyopathy, pericardial diseases) who are at increased risk in the event of a seizure.
d)Patients with persisting seizures (2 or more) per week in the post operative period.
e)Patients with global aphasia.
f)Hemodynamically unstable patients requiring ICU monitoring.
g)Recurrent intracranial tumors.
h)Pregnancy
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary measures-
Motor component of Fugl Meyer
scale
|
Baseline- day 0
Midpoint- after 12 sessions of therapy
Endpoint- at 3 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Modified Rankin scale
2. Functional ambulation classification
3. Modified Barthel index |
Baseline- day 0
Midpoint- after 12 sessions of therapy
Endpoint- at 3 months follow up |
|
|
Target Sample Size
|
Total Sample Size="22" Sample Size from India="22"
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)
|
10/05/2024 |
| 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="1" 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
|
Intracranial masses vary widely in severity, ranging from life-threatening lesions resistant to aggressive treatments to benign growths that only need occasional monitoring. Following surgery for primary brain tumors, it is not uncommon to observe a decline in neurological function. This deterioration can be attributed to various factors, such as perioperative ischemic injury, surgery in critical areas resulting in corresponding deficits, or the occurrence of supplementary motor area (SMA) syndrome subsequent to surgery in the premotor cortex. Consequently, enhancing the neurorehabilitation of emerging deficits holds significant promise for elevating the quality of life for these patients.
Hypothesis: Patients with new onset postoperative hemiparesis following surgical resection of intracranial mass lesion undergoing repetitive transcranial magnetic stimulation with comprehensive inpatient rehabilitation for 12 sessions will demonstrate better progress in motor and functional status as compared to those who undergo comprehensive inpatient rehabilitation alone. Rationale of the study: Transcranial Magnetic Stimulation [rTMS] along with rehabilitation has demonstrated positive effects on motor and functional recovery following loss of blood supply to the brain. Individuals with intracranial mass lesions may have hemiparesis as a sequelae, the beneficial effects (if any) of rTMS in this population is not clear. This study compares the functional recovery of individuals presenting with post-op (surgical resection of intracranial mass lesion) hemiparesis undergoing the standard of care i.e. in-patient rehabilitation with transcranial magnetic stimulation and the outcomes in individuals who undergo in-patient rehabilitation only. This is a Prospective interventional trial . Participants will be screened for the above inclusion and exclusion criteria (mentioned already) following which the participants who are willing to give an informed consent will be recruited.
Patients will be divided into an age matched control group and an intervention group to receive in-patient rehabilitation (standard of care) or in-patient rehabilitation with additional rTMS sessions (1Hz, 120% RMT, 1200 pulses, 20minutes, 12 sessions) respectively. All participants shall receive an individualized in-patient rehabilitation program with a goal of improving functional status. This will consist of cognitive assessment and therapy, physiotherapy, occupational therapy, psychosocial assessment & strategies. Participants in the rTMS group will undergo additional 20 minutes of low frequency rTMS applied to the M1 area in the unaffected hemisphere to suppress its excitability. Study Duration: 18 Months. Frequency: 5-6 sessions per week , total of 12 sessions. Sample size: 22 (11 in control group, 11 in intervention group)
Randomization: No Description of the device: Repetitive transcranial magnetic stimulation will be performed by a single investigator, using a MagVenture MagPro R100 stimulator equipped with a liquid-cooled figure-of-eight coil (each loop 70 mm in diameter). The coil would be angled 45 degrees to the sagittal plane, with the handle pointing backwards, to ensure optimal stimulus delivery. The coil would be systematically moved around the scalp and pulses would be delivered while noting the movements of the first dorsal interosseus muscle (FDI). Magnetic stimulation will be applied at 120% of the resting motor threshold (rMT) at 1 Hz frequency. A total of 1200 pulses will be generated during each session. Dosing parameters are based on previous studies. Each session will be of 20minutes and each subject will receive 12 once daily rTMS session for 5-6 days per week.
The outcome measures (mentioned already) will be recorded at baseline (Day 0), midpoint (session 12) and the endpoint (at 3 months follow up). Monitoring for adverse events will be done throughout the study period. |