Reduction of tremor in essential tremor patients by use of a new anti-tremor device

Not Applicable

Completed

• Conditions: Reduction of tremor in patients with essential tremor with a dominant forearm tremor.; Nervous System Diseases; Essential tremor

• Registration Number: ISRCTN17323638
• Lead Sponsor: Reinier de Graaf Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-10-19
• Study Start: 2023-05-30
• Last Update Posted: 28 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Diagnosed with essential tremor
2. Substantial perceived disability due to tremor in the arm, assessed from Bain and Findley ADL score (>30)
3. Tremor severity score >13 on subset (ADL tasks and upper-limb tasks) of the TETRAS scale
4. Dominant wrist flexion-extension and forearm pronation-supination tremor
5. Above 18 years old

Exclusion Criteria

1. Dominant shoulder internal-external rotation tremor
2. Dominant elbow flexion-extension tremor
3. Excessive alcohol consumption, as defined in the Dutch GGZ guidelines on alcohol use
4. Previous or planned deep brain stimulation (DBS) at the time of study enrollment that interferes with testing
5. Previous or planned thalamotomy procedure, including stereotactic thalamotomy, gamma knife radio surgical thalamotomy, and focused ultrasound for the treatment of tremor at the time of study enrollment that interferes with testing
6. Change in medications related to tremor disorder in the 30 days prior to study enrollment
7. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin on the forearm or hand that would interfere with wearing the orthosis during the clinical investigation
8. Peripheral neuropathy affecting the tested upper extremity (e.g. carpal tunnel syndrome)
9. The suspicion or confirmation that head tremor may cause impairment in performing ADL tasks
10. Diagnosed Parkinson’s disease, this includes the presence of parkinsonian features
11. Diagnosed functional tremor
12. Diagnosed physiologic tremor
13. Diagnosed cerebellar tremor
14. Diagnosed multiple sclerosis (MS)
15. Diagnosed ataxia
16. Patients with an amputation of one or both upper extremities.
17. Subjects with restricted movement or restricted muscle function in the arm and or hand (e.g. contractures)

Study & Design

• Study Type: Interventional
• Study Design: Not specified