Status:
RECRUITING
Effectiveness of STIL Orthosis in PD
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
The Dutch Brain Foundation
Conditions:
Parkinson&Amp;#39;s Disease
Action Tremor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Parkinson's disease is a neurodegenerative condition that leads to uncontrollable shaking (tremor), which can substantially impair everyday activities. The goal of this clinical trial is to learn if t...
Detailed Description
* \<b\>Background\</b\>: Tremor is a common symptom in people with Parkinson's disease (PD), affecting 75% of patients. While PD tremor usually occurs at rest, 46-93% of patients also have action trem...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06886178
Start Date
November 19 2024
End Date
June 1 2025
Last Update
March 20 2025
Active Locations (1)
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1
Donders Institute for Brain, Cognition and Behaviour
Nijmegen, Gelderland, Netherlands, 6511EN