| CTRI Number |
CTRI/2024/04/065811 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Theraputic] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Transcranial Magnetic stimulation in Writers cramp patients |
|
Scientific Title of Study
|
Repetitive Transcranial Magnetic stimulation to the inferior parietal lobule in task specific focal hand dystonia;A crossover;sham-control ,blinded outcome assessment study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| I-1610 |
Other |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRoopa Rajan |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no.-708,Cardio Neuro centre , AIIMS, Ansari Nagar,New Delhi-11002
New Delhi
DELHI
11002
India |
| Phone |
7025882507 |
| Fax |
|
| Email |
roopaajan@aiims.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRoopa Rajan |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no.-708,Cardio Neuro centre , AIIMS, Ansari Nagar,New Delhi-11002
New Delhi
DELHI
11002
India |
| Phone |
7025882507 |
| Fax |
|
| Email |
roopaajan@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Deblina Biswas |
| Designation |
Project Research Scientist-1 |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no-708, Cardio Neuro Centre , AIIMS, Ansari Nagar, New Delhi-110029.
New Delhi
DELHI
110029
India |
| Phone |
9123947037 |
| Fax |
|
| Email |
deblinabiswas1991@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
AIIMScampus , Ansari nagar east,New Delhi-11002 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Deblina Biswas |
AIIMS |
Ansari Nagar, New Delhi-110029
New Delhi
DELHI |
9123947037
deblinabiswas1991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,AIIMS,New Delhi- 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G248||Other dystonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Repetitive transcranial magnetic stimulation .SHAM or REAL. |
In this crossover study, 50 patients with task specific FHD will be randomized to receive 5 daily sessions of either low frequency (1Hz) inhibitory rTMS [Intervention] or Sham stimulation [Control] over the inferior parietal lobule (IPL).After a washout period of 2 weeks, participants will receive the alternate intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
Inclusion criteria-Patients meeting all of the following criteria will be
included in the study: a) Diagnosis of isolated, task specific focal hand dystonia as per MDS consensus update on phenomenology and classification of dystonia1 by 2 independent movement disorder specialists.b) Age 18-60 years2 .c) Not received BONT injections in the past 4 months.d) No localscalp infections/ wounds
e) Able to give informed consent.
|
|
| ExclusionCriteria |
| Details |
.3. Exclusion criteria
Participants meeting any of the following the criteria will be
excluded from the study a) History of brain tumour, stroke,
traumatic brain injury, epilepsy or seizure in lifetime.
b) History of major depression, psychosis
c) Implanted pacemaker, intracardiac lines, pumps or
stimulators, or metallic foreign bodies inside the eye or
skull. (Dental fillings and braces are allowed)
d) Pregnancy (negative UPT in 2 weeks)
Age and gender matched Healthy volunteers, with no known neurological complaints will be included for validation of fMRI, electrophysiology and kinematic protocols.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome will be the Writer’s Cramp Rating Scale (WCRS)
immediately after the intervention session. |
The primary outcome will be the Writer’s Cramp Rating Scale (WCRS)
immediately after the intervention session. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes will include kinematic analysis
(accelerometry, goniometry, handwriting kinematics), patient global impression of change scale, resting
and task based functional MRI assessments. |
1day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="3"
Months="0"
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
|
. Summary - In this crossover study, 50 patients with task specific FHD will be randomized to receive 5 daily sessions of either low frequency (1Hz) inhibitory rTMS [Intervention] or Sham stimulation [Control] over the inferior parietal lobule (IPL).After a washout period of 2 weeks, participants will receive the alternate intervention. The primary outcome will be the Writer’s Cramp Rating Scale (WCRS) immediately after the intervention session. Secondary outcomes will include kinematic analysis (accelerometry, goniometry, handwriting kinematics), patient global impression of change scale, resting and task based functional MRI assessments. We expect to generate novel data that will deepen the understanding of the pathophysiological mechanisms in FHD and contribute to a non-invasive, efficacious and safe treatment strategy for the same. |