Testing the STIL Orthosis for tremors in Parkinson's disease
The Effect of the STIL Orthosis on Action Tremor Severity in People With Parkinson's Disease
This study is testing whether a new device called the STIL Orthosis can help reduce tremors in people with Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT06886178 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the STIL Orthosis in reducing action tremors in individuals with Parkinson's disease. Participants will be assessed under three conditions: wearing the STIL Orthosis, wearing a sham orthosis without dampening, and not wearing any orthosis at all. The severity of tremors will be measured using the TETRAS scale to determine if the STIL Orthosis provides significant improvement. The study will also gather data on user satisfaction and any potential adverse effects associated with the device.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with Parkinson's disease who experience action tremors in one or both arms.
Not a fit: Patients with other neurological disorders or those who have been diagnosed with Parkinson's disease for seven years or more may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients with Parkinson's disease by reducing tremors and enhancing daily functioning.
How similar studies have performed: Previous studies have shown promising results with the STIL Orthosis in patients with essential tremor, suggesting potential effectiveness in Parkinson's disease as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is at least 18 years of age. * Willing to sign the informed consent. * Diagnosed with Parkinson's disease by a neurologist or movement disorders specialist. * Action tremor in one or two arms (clinical severity score of at least 2 on their dominant side, on MDS-UPDRS items 3.15 or 3.16). * At least experiencing wrist flexion/extension or forearm pronation/supination tremor. Exclusion Criteria: * Diagnosed with any other neurological disorder, such as epilepsy, Essential tremor, functional tremor, physiologic tremor, cerebellar tremor, MS, spasticity, ataxia, dystonia, Alzheimer's disease or dementia, atypical parkinsonism, peripheral neuropathy affecting the arms (e.g., carpal tunnel syndrome). * Disease duration of \>= 7 years. * Using a high dose of dopamine agonists, i.e., a levodopa equivalent dose (LED) of \>150 mg for agonists, equivalent to approximately 1.5 mg pramipexole and 5 mg rotigotine). This is done, because dopamine agonists can have longer-lasting effects beyond 12 hours after the last dose (which is our criterion for OFF, to ensure feasibility for participants). If patients take higher doses of dopamine agonists, they may still be \*ON\* at the time of study. * Experiencing severe bradykinesia/rigidity, to such an extent that the participant is unable to perform the ADL tasks (drinking, eating, pouring water). * Limited movement or muscle function in the arm/hand (for contractures or muscle diseases), or loss of muscle function in one arm (e.g., due to paralysis, or amputation). * Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin on the forearm or hand that would wear the orthosis during the clinical investigation. * Consuming excessive alcohol (more than 21 glasses per week for men and 14 glasses per week for women), as defined in the GGZ guidelines on alcohol use. * Having received a botulinum toxin injection to suppress hand tremor in the past six months, or planned in the coming 60 days. * Previous or planned Deep Brain Stimulation (DBS) at time of study enrollment that interferes with testing. * Change in any tremor medication in the past 30 days or planned during the period of testing. * A hand circumference smaller than 170 mm, or larger than 250 mm. * An upper arm circumference smaller than 180 mm, or larger than 350 mm. * Patch/band-aid allergies. * Participant is unable to communicate with the investigator and staff due to: (1) not mastering the Dutch and English language, (2) blindness, (3) deafness, (4) illiteracy. * Pregnancy or anticipated pregnancy at time of study enrollment. * Any health condition that in the neurologist's opinion should preclude participation in this study.
Where this trial is running
Nijmegen, Gelderland
- Donders Institute for Brain, Cognition and Behaviour — Nijmegen, Gelderland, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.