Reduction of tremor in patients with essential tremor with a dominant forearm tremor. Nervous System Diseases Essential tremor
Conditions
Interventions
An algorithm within the CRF software, which includes the API that is used to acquire the motion data, will randomly determine the order of the sham device and intervention. Only the investigator can s
and wearing the novel anti-tremor orthosis. The sham device, albeit identical in weight and appearance to the orthosis, contained no damping elements designed for tremor suppression and did not restra
Sponsors
Reinier de Graaf Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at a single timepoint: 1. Tremor severity is measured using the TETRAS scale (score: 0-28), assessed by neurologists with specialization in movement disorders, for each intervention 2. Tremor power is measured using accelerometry data, recorded by two inertial movement units (IMU) located at the wrist and hand of the subjects, during each intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at a single timepoint: 1. Patient satisfaction with the sham device and the orthosis, measured using the Dutch Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST), ranging on a scale from 1 (not at all satisfied) to 5 (very satisfied) 2. Adverse events, both reported by subjects as well as observed by the investigator | — |
Countries
Netherlands
Outcome results
None listed