Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411028
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-08
Brief Title:
Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia An Exploratory Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAT
Brief Summary:
Tremor occurs in up to 55 of dystonia patients which is known as dystonic tremor syndrome DTS Tremor can be present in the body part affected by dystonia dystonic tremor DT or an unaffected body part tremor associated with dystonia TAWD DTS can be treated with botulinum neurotoxin BoNT injections but BoNT is effective in only about 60-70 of patients It is unknown which patients benefit most from BoNT treatment We aim to explore the associations between clinical and pathophysiological tremor characteristics and BoNT efficacy To do so we will measure clinical electrophysiological ultrasonographic and functional magnetic resonance imaging fMRI characteristics before the start of BoNT treatment and measure BoNT efficacy after three three-monthly BoNT sessions
Detailed Description:
Rationale Tremor occurs in up to 55 of dystonia patients which is known as dystonic tremor syndrome DTS Tremor can be present in the body part affected by dystonia dystonic tremor DT or an unaffected body part tremor associated with dystonia TAWD DTS can be treated with botulinum neurotoxin BoNT injections but BoNT is effective in only about 60-70 of patients It is unknown which patients benefit from BoNT treatment This highlights the need for personalized treatment
Objective The primary objective is to explore the differences in BoNT efficacy between DT and TAWD of the upper extremity Secondary objectives are to explore the electrophysiological and cerebral differences between DT and TAWD of the upper extremity explore the associations between clinical electrophysiological ultrasonographic and functional magnetic resonance imaging fMRI tremor characteristics and BoNT efficacy in DTS of the upper extremity and explore the agreement between a clinical assessment polymyography PMG and muscle ultrasound MUS on muscle selection in DTS of the upper extremity
Study design Explorative prospective multi-centre cohort study Study population 60 adults with DTS 30 DT 30 TAWD of the upper extremity who start 12-weekly BoNT treatment as part of standard care
Main study parametersendpoints The primary outcome measure is clinical tremor severity quantified by the TRG Essential Tremor Rating Assessment Scale TETRAS at 28 weeks We will also collect clinical electrophysiological ultrasonographic and fMRI measures and patient-reported outcomes
Nature and extent of the burden and risks associated with participation benefit and group relatedness Subjects do not benefit from participation The risk of the extra study procedures is negligible The study procedures are harmless but may be tiring The time burden consists of five extra hours spent at the hospital divided across three visits and filling in questionnaires one hour The baseline visit for MRI scanning and the visit at 28 weeks are extra compared to standard care
Objective The primary objective is to explore the differences in BoNT efficacy between DT and TAWD of the upper extremity Secondary objectives are to explore the electrophysiological and cerebral differences between DT and TAWD of the upper extremity explore the associations between clinical electrophysiological ultrasonographic and functional magnetic resonance imaging fMRI tremor characteristics and BoNT efficacy in DTS of the upper extremity and explore the agreement between a clinical assessment polymyography PMG and muscle ultrasound MUS on muscle selection in DTS of the upper extremity
Study design Explorative prospective multi-centre cohort study Study population 60 adults with DTS 30 DT 30 TAWD of the upper extremity who start 12-weekly BoNT treatment as part of standard care
Main study parametersendpoints The primary outcome measure is clinical tremor severity quantified by the TRG Essential Tremor Rating Assessment Scale TETRAS at 28 weeks We will also collect clinical electrophysiological ultrasonographic and fMRI measures and patient-reported outcomes
Nature and extent of the burden and risks associated with participation benefit and group relatedness Subjects do not benefit from participation The risk of the extra study procedures is negligible The study procedures are harmless but may be tiring The time burden consists of five extra hours spent at the hospital divided across three visits and filling in questionnaires one hour The baseline visit for MRI scanning and the visit at 28 weeks are extra compared to standard care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL8654609124 | OTHER | CCMO-Register | None |