RECRUITING

MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)

Quick Facts

Study Start:2024-06-10

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06367608

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Clinical diagnosis of moderate to severe TSFD with impact in their daily function or occupation function 2. Patients who failed to response or had unsatisfactory response to the first treatment, such as Botulinum toxin treatment or DBS or refuse these alternative options 3. Age greater than 21 and less than 75 years 4. Subjects who are able and willing to give consent and able to attend all study visits, 5. Documented chronic, symptoms for more than 6 months duration 6. Pallidotomy is feasible based on evaluation of imaging studies 7. Patient able to communicate sensations during the ExAblate TcMRgFUS treatment 8. Two members of the medical team have agreed upon inclusion and exclusion criteria	1. Patient with contraindications to MRI such as severe claustrophobia and metallic implants incompatible with MRI. 2. Presence of generalized dystonia or involvement of two or more contiguous body regions (such as Arm along with neck) 3. Severe psychiatric disorder such as uncontrolled depression, anxiety, bipolar disorder, prior attempt at suicide or suicide ideation in preceding 12 months 4. Life expectancy less than 12 months 5. Anticoagulant or antiplatelet medications as well as underlying coagulopathy 6. Pregnant ladies or women of childbearing age who are sexually active and not using contraception 7. Inability to provide informed consent, for example due to underlying cognitive impairment or aphasia 8. Presence of intracranial mass or an acute intracranial abnormality 9. Subjects with unstable cardiac status such as unstable angina pectoris, documented myocardial infarction within 6 months of protocol entry or ejection fraction less than 40 10. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders(DSM-IV) 11. Severe hypertension (diastolic blood pressure \> 100 on medication or persistently elevated systolic blood pressure\>140 mmHg despite adequate antihypertensive medications) 12. History of intracranial hemorrhage, traumatic brain injury or thalamic stroke. 13. Cerebrovascular disease (multiple cerebrovascular accident's (CVA) or CVA within 6 months) 14. Subjects with life-threatening systemic disease that include and not limited to the following will be excluded from the study participation: HIV, Liver Failure, blood dyscrasias, etc. 15. Subjects with a history of seizures within the past year 16. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hours of total table time.)

Inclusion Criteria

Exclusion Criteria

1. Clinical diagnosis of moderate to severe TSFD with impact in their daily function or occupation function
2. Patients who failed to response or had unsatisfactory response to the first treatment, such as Botulinum toxin treatment or DBS or refuse these alternative options
3. Age greater than 21 and less than 75 years
4. Subjects who are able and willing to give consent and able to attend all study visits,
5. Documented chronic, symptoms for more than 6 months duration
6. Pallidotomy is feasible based on evaluation of imaging studies
7. Patient able to communicate sensations during the ExAblate TcMRgFUS treatment
8. Two members of the medical team have agreed upon inclusion and exclusion criteria

1. Patient with contraindications to MRI such as severe claustrophobia and metallic implants incompatible with MRI.
2. Presence of generalized dystonia or involvement of two or more contiguous body regions (such as Arm along with neck)
3. Severe psychiatric disorder such as uncontrolled depression, anxiety, bipolar disorder, prior attempt at suicide or suicide ideation in preceding 12 months
4. Life expectancy less than 12 months
5. Anticoagulant or antiplatelet medications as well as underlying coagulopathy
6. Pregnant ladies or women of childbearing age who are sexually active and not using contraception
7. Inability to provide informed consent, for example due to underlying cognitive impairment or aphasia
8. Presence of intracranial mass or an acute intracranial abnormality
9. Subjects with unstable cardiac status such as unstable angina pectoris, documented myocardial infarction within 6 months of protocol entry or ejection fraction less than 40
10. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders(DSM-IV)
11. Severe hypertension (diastolic blood pressure \> 100 on medication or persistently elevated systolic blood pressure\>140 mmHg despite adequate antihypertensive medications)
12. History of intracranial hemorrhage, traumatic brain injury or thalamic stroke.
13. Cerebrovascular disease (multiple cerebrovascular accident's (CVA) or CVA within 6 months)
14. Subjects with life-threatening systemic disease that include and not limited to the following will be excluded from the study participation: HIV, Liver Failure, blood dyscrasias, etc.
15. Subjects with a history of seizures within the past year
16. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hours of total table time.)

Contacts and Locations

Study Contact

Dheeraj Gandhi, MD

CONTACT

(248)-497-8856

dgandhi@umm.edu

Kaitlyn Henry, MS

CONTACT

410-328-0939

khenry@som.umaryland.edu

Study Locations (Sites)

University of Maryland Medical Center

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-10

Study Completion Date2028-06

Study Record Updates

Study Start Date2024-06-10

Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

Task-Specific Focal Dystonia