An interventional study of Stanford Glove in Parkinson Disease, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 92 Years. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms. vCR will be administered with a device called the Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as Levodopa and/or deep brain stimulation. Patients will be followed for 14 months.
The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with Parkinson's disease and inform the investigators on whether unilateral stimulation could be as effective as bilateral stimulation at producing clinically significant improvements in symptoms.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's planned enrollment of 34 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Ages 18 or older
Exclusion Criteria:
Participants will receive active stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR
Device: Stanford Glove
Participants will receive sham stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR
Device: Stanford Glove
The non-invasive neuromodulation hardware system comprises two wireless controllers/battery packs which are fastened to the top of each hand via an adjustable elastic strap. Each controller is equipped with four vibrotactile fingertip stimulators, also known as tappers. There is a total of eight tappers (for index, middle, ring and pinkie of each hand) per system.
Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score
Mean change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score. Minimum score - 0 indicates normal functioning Maximum score - 132 indicated severe impairment Lower scores indicate greater functionality and higher scores indicate severe impairment in functionality.
Time frame: Baseline and month 6
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Dec 2026, 23 months later.
Of 1,296 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 23 months is close to that.
Counting every sponsor, half of 1,369 studies reached it within 24 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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