Reduce tremor using vibrotactile stimulation
- Trial ID
- NCT05881460
- Official Title
- Vibrotactile Coordinated Reset: a Non-invasive Treatment for Parkinson's Disease
- Goal
- Reduce tremor using vibrotactile stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Synergic Medical Technologies, Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson Disease
- Interventions
- Active vibrotactile coordinated reset, Sham vibrotactile coordinated reset
Plain-Language Summary
The trial aims to ease core motor problems in Parkinson's, like slowness, stiffness, tremor, and walking or balance trouble, by targeting the abnormal, overly synchronized brain rhythms that contribute to them. It uses a non-invasive wearable that delivers "vibrotactile coordinated reset," brief, precisely timed skin vibrations meant to desynchronize those pathological neural patterns and potentially improve movement, with participants randomized to active or sham vibration; the device is used alongside usual Parkinson's medications and does not replace levodopa. Enrollment is for people 45 to 85 with idiopathic Parkinson's and moderate bilateral disease (Hoehn and Yahr II-IV on meds), who can stand and walk unassisted, are levodopa-responsive with stable PD medications for at least four weeks, live near the clinic and can use basic technology, while those with prior brain surgery or neurostimulators, other significant neurological conditions, severe depression, or recent trial participation are excluded.
Locations
- Oregon Health & Science Institution, Portland, Oregon, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Active vibrotactile coordinated reset. The trial aims to ease core motor problems in Parkinson's, like slowness, stiffness, tremor, and walking or balance trouble, by targeting the abnormal, overly synchronized brain rhythms that contribute to them. It uses a non-invasive wearable that delivers "vibrotactile coordinated reset," brief, precisely timed skin vibrations meant to desynchronize those pathological neural patterns and potentially improve movement, with participants randomized to active or sham vibration; the device is used alongside usual Parkinson's medications and does not replace levodopa. Enrollment is for people 45 to 85 with idiopathic Parkinson's and moderate bilateral disease (Hoehn and Yahr II-IV on meds), who can stand and walk unassisted, are levodopa-responsive with stable PD medications for at least four weeks, live near the clinic and can use basic technology, while those with prior brain surgery or neurostimulators, other significant neurological conditions, severe depression, or recent trial participation are excluded.
- Who can participate?
- Participants must be between 45 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 5 months.