Effectiveness of STIL Orthosis in PD

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Mar 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the STIL Orthosis, a device designed to help reduce tremors in people with Parkinson's disease. Tremors can make daily activities difficult, and the researchers want to find out if this orthosis can effectively lessen the shaking. They will also look at how comfortable and easy to use the orthosis is for participants and whether there are any side effects. Participants will be monitored in three different situations: while wearing the STIL Orthosis, while wearing a similar device that does not help (a sham), and without any device at all.

To join the trial, participants need to be at least 18 years old, have a confirmed diagnosis of Parkinson's disease, and experience noticeable tremors in one or both arms. However, people with certain other neurological disorders, severe movement difficulties, or specific health conditions will not be eligible to participate. Those who join can expect to wear the STIL Orthosis during the study, and their tremors will be measured to see if the device makes a difference. This trial is currently recruiting participants, and it’s a valuable opportunity for those looking for new treatment options for their tremors.

Gender

ALL

Eligibility 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.