NCT06038097

Brief Summary

Generalized dystonia is treated with pallidotomy. This is based on observational data which is significantly limited by publication bias and there are no RCTs. The case reports focus on successful outcomes and case series have an inherent selection bias. Bilateral pallidotomy has been used in our institute in a series of patients with generalized and segmental dystonia and have been seen to show good efficacy. However, the existing literature suggests that it is also associated with dysphagia and dysarthria in some cases and thus simultaneous bilateral pallidotomy is not preferred in several centres. However, our center routinely performs simultaneous bilateral pallidotomy. The response rates and compliations of the procedure have not been systematically studied in RCT and we need to generate data on the efficacy and safety of Pallidotomy on generalized and segmental dystonia. This randomized controlled trial will fill the void in knowledge in this field.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Oct 2023Mar 2027

First Submitted

Initial submission to the registry

September 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

3.3 years

First QC Date

September 8, 2023

Last Update Submit

September 8, 2023

Conditions

Dystonia

Keywords

DystoniaSegmental dystoniaGeneralized dystonia

Outcome Measures

Primary Outcomes (2)

  • BFM Dystonia disability scale

    To compare the BFM Dystonia disability scale 6 weeks following bilateral simultaneous radiofrequency pallidotomy (early treatment arm) with the BFM Dystonia disability scale 6 weeks following acceptance of the procedure in those who were randomized to undergo the procedure atleast 12 weeks after accepting the the procedure (delayed treatment arm)

    6 weeks

  • Adverse effects: New onset or worsening Dysphagia or dysarthria

    To study the incidence of new onset or worsening dysphagia or dysarthria in patients with dystonia undergoing bilateral simultaneous pallidotomy

    12 weeks

Secondary Outcomes (3)

  • 20% improvement in BFM Dystonia disability scale

    6 weeks

  • 20% improvement in BFM Dystonia movement scale

    6 weeks

  • Adverse effects

    12 weeks

Study Arms (2)

Early intervention arm

EXPERIMENTAL

Radiofrequency Pallidotomy at earliest available date

Procedure: Radiofrequency Pallidotomy

Delayed intervention arm

NO INTERVENTION

Radiofrequency pallidotomy offered at 12 weeks following agreeing to participate in the study

Interventions

Radiofrequency PallidotomyPROCEDURE

Radiofrequency bilateral simultaneous pallidotomy

Early intervention arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with generalized, segmental or focal dystonias who are being considered for simultaneous bilateral radiofrequency pallidotomy.
  • Of all ages and gender

You may not qualify if:

  • Those who deny consent
  • Pregnant ladies and women of childbearing potential without adequate contraception
  • Those who have undergone botulinum toxin injection in the last 12 weeks or those who are being planned for the same in the upcoming 12 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences, New Delhi

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arunmozhimaran Elavarasi, MD DM

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arunmozhimaran Elavarasi, MD DM

CONTACT

+919013844274arun_ela@yahoo.com

Padma Srivastava MV, MD DM

CONTACT

+919868398261vasanthapadma123@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 14, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

September 14, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

De-identified patient data will be shared on approaching through proper channel through ethics committee AIIMS, New Delhi

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Will become available after the project is completed, will be available for 5 years atleast after completition of the trial
Access Criteria
De-identified patient data will be shared on approaching through proper channel through ethics committee AIIMS, New Delhi

Locations

IN(1)