| CTRI Number |
CTRI/2024/08/072913 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Of Botulinum Toxin Type A Injection Over Conservative Treatment in dystonic movements associated to specific tasks |
|
Scientific Title of Study
|
Comparative Efficacy Of Botulinum Toxin Type A Injection Over Conservative Treatment In Task Specific Dystonia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhajyoti Ghosh |
| Designation |
Post Graduate Trainee (MD) |
| Affiliation |
Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata |
| Address |
Physical Medicine and Rehabilitation Dept IPGMER and SSKM Hospital, AJC Bose Road, BHOWANIPORE, KOLKATA
Kolkata
WEST BENGAL
700020
India |
| Phone |
8240302516 |
| Fax |
|
| Email |
subhajyotighosh85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Firdaus Kamal |
| Designation |
Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata |
| Address |
Physical Medicine and Rehabilitation Dept, IPGMER and SSKM Hospital, AJC Bose Road, Bhowanipore, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830219554 |
| Fax |
|
| Email |
kamal.firdaus.kamal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Firdaus Kamal |
| Designation |
Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research and SSKM Hospital ,Kolkata |
| Address |
Physical Medicine and Rehabilitation Dept, IPGMER and SSKM Hospital, AJC Bose Road, Bhowanipore, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830219554 |
| Fax |
|
| Email |
kamal.firdaus.kamal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata, AJC Bose Road, Bhowanipore Kolkata PIN 700020 |
|
|
Primary Sponsor
|
| Name |
IPGMER & SSKM Hospital |
| Address |
244, A.J.C.Bose Road
Bhowanipore, Kolkata, West Bengal- 700020 |
| Type of Sponsor |
Government medical college |
|
|
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 Subhajyoti Ghosh |
Institute of Post Graduate Medical Education and Research and SSKM Hospital ,Kolkata |
Physical Medicine and Rehabilitation Dept, IPGMER and SSKM Hospital, Kolkata 244 AJC Bose Road, Bhowanipore, Kolkata, West Bengal . PIN 700020
Kolkata
WEST BENGAL |
8240302516
subhajyotighosh85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R RESEARCH OVERSIGHT COMMITTEE |
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 |
| Intervention |
Botulinum Toxin Type A |
Botulinum Toxin Type A Injection in specified muscles under Ultrasound guidance dependant on body weight, type of muscle, once and followed up at 1, 4, 12 weeks |
| Comparator Agent |
Oral Trihexiphenidyl |
Oral Trihexiphenidyl dose initially starting from 1 mg, weekly increased by 1 mg , by end of 1st month, 2 mg thrice daily , then 3mg thrice daily by end of 2nd month, finally 12mg given by end of 3rd month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient giving consent
2.FAHN MARSDEN DYSTONIA SCORE more than or equal to 2
3.Symptoms since at least 3 months,
4. Patients with selective writing difficulty, showing improvement with diagnostic intramuscular lignocaine injection
|
|
| ExclusionCriteria |
| Details |
1.Allergy to botulinum toxin injection
2.Patients presenting with other forms of task specific dystonia as musicians etc
3. Local injection site infection.
4. Patients presenting with hand deformity or contracture.
5.Coagulation disorders,
6. Patients with cognitive deficit
7. Patients injected with botulinum toxin injection in past 3 months.
pregnant patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FAHN MARSDEN DYSTONIA SCORE for hand improvement |
1, 4 , 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/09/2024 |
| 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
|
TITLE COMPARATIVE EFFICACY OF BOTULINUM TOXIN TYPE A INJECTION OVER CONSERVATIVE TREATMENT IN TASK SPECIFIC DYSTONIA
OBJECTIVE To assess improvement in fahn marsden dystonia score for hand in patients injected with botulinum toxin type A injection at 1, 4, 12 weeks over oral trihexiphenidyl under ultrasound guidance in task specific dystonia.
RESEARCH HYPOTHESIS there is improvement in fahn marsden dystonia score in patients receiving botulinum toxin type A injection under ultrasound guidance over oral trihexiphenidyl in task specific dystonia patients at 1, 4, 12 weeks
BACKGROUND OF PRESENT STUDY task specific dystonia is one common cause of significant comorbidity in world. one common form is writer cramp. these symptoms may later aggravate to involve other activities shaving, grooming etc. slowly handwriting becomes less legible causing poor quality of life .prevalence estimates from 11 to 50 and 101 to 430 per million . 10 to 20 % have significant family history. . Regular highly skilled activities performance trigger this. imbalance in basal ganglia precipitate this. including GABAergic pathways. oral trihexiphenidyl usually is used but has not been shown to have significant improvement alone. dose ranges average 41mg in adults to 24 in children, though have high anticholinergic side effects. . botulinum toxin type A injection has shown standard of care in writer cramp with minimal adverse reactions. mechanism includes acetyl choline transmission inhibition at neuromuscular junction. local muscle weakness is a known complications shown in various studies. Though several placebo controlled trials are present with Botulinum toxin type A injection, we intend to compare benefits of botulinum toxin injection over oral trihexiphenidyl in our study as evidence of such studies are less.
METHODOLOGY study design/ experiment parallel group, open label randomized controlled trial.
study duration 18 months
study place dept of physical medicine and rehabilitation, IPGMER AND SSKM hospital,. kolkata
study population patients attending OPD of PMR dept, IPGMER fulfilling inclusion and exclusion criteria
sample size total 78 ( 39)
place of study department of PHYSICAL MEDICINE AND REHABILITATION , IPGMER AND SSKM HOSPITAL, KOLKATA |