NL-OMON48254
Not yet recruiting
Phase 2
The effect of the STIL brace on forearm tremor - a double-blind randomized crossover study - Suppression of the forearm tremor with the STIL brace
Reinier de Graaf Groep0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Reinier de Graaf Groep
- Enrollment
- 20
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Patients over 18 years old
- •\* Competent and willing to sign informed consent
- •\* Significant disability due to forearm tremor. (ADL score of 3 or above in one
- •of the upper limb items and a minimum subset score of 38 across all upper limb
- •items. Scored for the most affected hand with the Bain and Findley ADL scale)
Exclusion Criteria
- •\* Excessive alcohol consumption, as defined in the GGZ guidelines
- •\* Implanted electrical medical device, such as a pacemaker, defibrillator, or
- •deep brain stimulator
- •\* Previous thalamotomy procedure, including stereotactic thalamotomy, gamma
- •knife radio surgical thalamotomy, and focused ultrasound for the treatment of
- •\* Change in medication in the 30 days prior to study enrollment
- •\* Taking medication known to exacerbate tremor
- •\* Suspected or diagnosed epilepsy
- •\* Swollen, infected, inflamed areas, or skin eruptions, open wounds, or
- •cancerous lesions of skin at stimulation site.
Outcomes
Primary Outcomes
Not specified
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