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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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C71||Malignant neoplasm of brain,  
 
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
 
 
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.

 
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