Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367608
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-04-11
Brief Title:
MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia TSFD
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Phase 1 Clinical Trial for MR Guided Focused Ultrasound FUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia TSFD
Status:
RECRUITING
Status Verified Date:
2024-06
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:
FUS Dystonia
Brief Summary:
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound MRgFUS for treating task specific focal hand dystonias TSFD TSFD is a type of dystonia that affects hand movements during specific tasks such as writing playing instruments or typing often causing involuntarily movements or cramping
Detailed Description:
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound MRgFUS for treating task specific focal hand dystonias TSFD TSFD refers to a condition where certain movements or tasks trigger involuntary muscle contractions particularly during specialized and repetitive activities like writing known as writers dystonia typing typists dystonia playing musical instruments musicians dystonia or engaging in sports like golf table tennis or juggling While TSFD affects around 12-15 of the general population its more common among athletes and musicians Writers dystonia for example typically starts with difficulty writing and hand cramping in the dominant hand possibly spreading to the arm and shoulder muscles over time In severe cases the other hand may also be affected Similarly typists dystonia can lead to finger flexion or extension issues during typing Musicians dystonia is another form seen in guitarists pianists harpists or flute players often emerging during the peak of their careers and significantly impacting musical performance These dystonias can be career-ending as they impair performance and rarely go into remission with onset often occurring around the age of forty
Surgical treatments for Task-Specific Focal Dystonia TSFD are less often explored than for other dystonias Thalamotomy targeting the ventro-oralis Vo nucleus has shown some promise for hand dystonias like writers cramp or musicians dystonia Anecdotally some benefit from deep brain stimulation DBS targeting the globus pallidus internus GPi has also been shown but large-scale studies for TSFD are lacking
Another promising approach is MR guided focused ultrasound thalamotomy a non-invasive procedure that uses real-time imaging to precisely target brain areas This method has already shown success in treating essential tremors and Parkinsons disease symptoms Recent studies and anecdotal cases have also demonstrated its potential for treating TSFD with improvements in symptoms observed in patients with writers cramp musicians dystonia and other related conditions
The Exablate MR Guided Focused Ultrasound Transcranial system is a device designed to overcome the limitations of delivering ultrasound through the intact skull It uses advanced technology like water-cooling acoustic correction algorithms and patient-specific CT data to ensure precise and safe delivery of ultrasound energy to targeted brain areas This pilot study protocol aims to utilize MR guided focused ultrasound thalamotomy as a treatment option for TSFD
Surgical treatments for Task-Specific Focal Dystonia TSFD are less often explored than for other dystonias Thalamotomy targeting the ventro-oralis Vo nucleus has shown some promise for hand dystonias like writers cramp or musicians dystonia Anecdotally some benefit from deep brain stimulation DBS targeting the globus pallidus internus GPi has also been shown but large-scale studies for TSFD are lacking
Another promising approach is MR guided focused ultrasound thalamotomy a non-invasive procedure that uses real-time imaging to precisely target brain areas This method has already shown success in treating essential tremors and Parkinsons disease symptoms Recent studies and anecdotal cases have also demonstrated its potential for treating TSFD with improvements in symptoms observed in patients with writers cramp musicians dystonia and other related conditions
The Exablate MR Guided Focused Ultrasound Transcranial system is a device designed to overcome the limitations of delivering ultrasound through the intact skull It uses advanced technology like water-cooling acoustic correction algorithms and patient-specific CT data to ensure precise and safe delivery of ultrasound energy to targeted brain areas This pilot study protocol aims to utilize MR guided focused ultrasound thalamotomy as a treatment option for TSFD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None