Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT05490277
Status
Not Yet Recruiting

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Conditions

  • Chronic Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Vibrotactile coordinated reset — DEVICE
    Participants will receive active vibrotactile coordinated reset (vCR) which sends gentle vibrations to the fingertips at a specific pattern. The purpose of the intervention is to test the efficacy of active vCR in comparison to sham vCR.
  • Sham vibrotactile coordinated reset — DEVICE
    Participants will receive sham vibrotactile coordinated reset (vCR) which sends gentle vibrations to the fingertips at a specific pattern. The purpose of the intervention is to test the efficacy of active vCR in comparison to sham vCR.

Study Details

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within stroke patients. vCR will be administered with a device called the Vibrotactile (VT) Brain Glove. vCR is expected to provide patients with a non-invasive therapy to aid in recovery from a stroke. This study will include a dedicated sham arm that will aid in understanding true treatment effects from vCR.

Key Dates

Start date
Jan 15, 2026
Status verified
Aug 2024
Primary completion
Nov 15, 2028
Completion
Nov 15, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Vibrotactile Coordinated Reset (vCR)
    Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain.
  • Sham Comparator: Sham Vibrotactile Coordinated Reset (vCR)
    Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. An inactive pattern of vibration to each fingertip is delivered which theoretically will not have the effects of active vCR.

Primary Outcome Measure

Fugl Meyer Assessment of Motor Recovery after Stroke change from baseline, 3 months, 4 months, 7months and 8 months [ Time Frame: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94303-

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By research site
Stanford University· Stanford, CA

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