| CTRI Number |
CTRI/2024/07/069987 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
a clinical trial to study effect of repetitive transcranial magnetic stimulation in gait and behavioral changes patients with progressive supranuclear gaze palsy |
|
Scientific Title of Study
|
Effect of rTMS on motor and nonmotor symptoms of progressive surpanuclear plasy : Randomised controlled 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 |
Dr Deepika Joshi |
| Designation |
Professor |
| Affiliation |
IMS, BHU, varanasi |
| Address |
Department of neurology, IMS, BHU,Varanasi 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9918978666 |
| Fax |
|
| Email |
drdeepikajoshi73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Janki Makani |
| Designation |
senior resident |
| Affiliation |
IMS, BHU, varanasi |
| Address |
sir sunderlal hospital, IMS, BHU, varanasi, uttar pradesh
same
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9099889038 |
| Fax |
|
| Email |
jnkmakani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika Joshi |
| Designation |
Professor |
| Affiliation |
IMS, BHU, varanasi |
| Address |
Department of neurology, IMS, BHU,Varanasi 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9918978666 |
| Fax |
|
| Email |
drdeepikajoshi73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of neurology,Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh,India
Pincode 221005 |
|
|
Primary Sponsor
|
| Name |
dr deepika Joshi |
| Address |
Department of Neurology, Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
pincode 221005 |
| 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 |
| drDeepika Joshi |
Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu Univresity |
Department of Neurology
Varanasi
UTTAR PRADESH |
9918978666
drdeepikajoshi73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics Committee, IMS, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: G231||Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
repetitive transcranial magnetic stimulation( placebo) |
2 sets of 5 daily sessions 1 month apart for 240 seconds of sham protocol mimicking intervention |
| Intervention |
repetitive transcranial nerve stimulation |
2 sets of 5 daily sessions 1 month apart with coil positioned 3 cm lateral to inion , 1 cm inferior to lateral cerebellum.
20 trains of 10 bursts with 8 second interval total 600 pulses in 240 seconds.
3 50 hz pulses repeated at the rate of 5 hz. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
probable or possible PSP defined by MDS criteria
ability to stand unassisted for 30 seconds and ability to walk independently with walker
MMSE 18 or more
on stable treatment of anticholinergic, dopaminergic , serotonergic sedative or NMDA receptor antagonist |
|
| ExclusionCriteria |
| Details |
history of cerebellar ataxia, subdural hematoma, space occupying lesion, hydrocephalus
prior vestibular disease
sensory deficit in feet
epilepsy and psychotic disorder active intake of antiseizure medication
pregnancy
presence of electrically, magnetically active implants or metal exposures that preclude use of rTMS |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
to study efficacy in motor and nonmotor symptoms after cerebellar rTMS in progressive supranuclear palsy compared to sham procedure
with parameters like
PSP rating scale
MDS non motor rating scale
UPDRS part III
PSP CDS
MOCA
FAB |
patient will be assessed at the time of enrollment, at 1 month and at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to look for non motor and behavioral changes in patients with PSP |
patient will be assessed at the time of enrollment, at 1 month and at 6 months |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/07/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
this is a randomized placebo controlled trial to assess the efficacy of repetitive transcranial magnetic stimuli in motor and non motor symptoms of progressive supranuclear palsy. this trial is conducted to assess various parameters and improvement in gait after the intervention. |