TheraBracelet Phase I

NCT03318341 | Completed Results DMC FDA Device

• 1 other identifier: 1R41HD090792-01A1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to test a new technology that may improve hand function impaired from a stroke, thereby improving independence and quality of life.

Conditions

Hand Function; Stroke; Upper Extremity; Hemiparesis; Cerebrovascular Accident; Stroke Rehabilitation

Keywords

physical stimulation; Subliminal stimulation; stroke rehabilitation; upper extremity; paresis; patient safety

Outcome Measures

Primary Outcomes (2)

• Safety - Occurrence of Device-Related Adverse Events (AE)

  Any worsening of hand sensation, dexterity, grip strength, upper limb pain, swelling, spasticity, skin irritation, or any other adverse events (assessed every week) that sustained until the end of the month or occurred at the end of the month.

  Two 1-month durations

• Feasibility - User Compliance in Wearing the Device

  Two 1-month durations

Study Arms (2)

Real then Sham

OTHER

Participants are instructed to wear the TheraBracelet device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. After 2-week washout, participants are again instructed to wear the device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. The device applies real stimulation in the first month. The device applies sham stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.

Device: Real Stimulation; Device: Sham Stimulation

Sham then Real

OTHER

Participants are instructed to wear the TheraBracelet device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. After 2-week washout, participants are again instructed to wear the device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. The device applies sham stimulation in the first month. The device applies real stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.

Device: Real Stimulation; Device: Sham Stimulation

Interventions

Real Stimulation DEVICE

The device applies wrist vibration at a subthreshold (imperceptible) level.

Real then Sham; Sham then Real

Sham Stimulation DEVICE

The device applies no vibration.

Real then Sham; Sham then Real

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years or older
• Time since stroke: \> 3 months
• Those with at least some movement in the affected upper limb
• Ability to put on the device at home
• Ability to perform the Box and Block Test with a score \> 0

You may not qualify if:

• Comorbidity such as neuropathy, orthopaedic conditions in the hand
• Compromised skin integrity of the hand/wrist.
• Participation in an upper limb rehabilitation program concurrently
• Pregnancy
• A language barrier or cognitive impairment that precludes following
• Individuals whose swelling changes dramatically during the day
• Participant has received Botulinum toxin injection in the past 3 months
• Inability or unwillingness of subject or legal guardian/representative to give informed consent

Sponsors & Collaborators

• TheraBracelet, Inc.: lead
• Medical University of South Carolina: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Seo NJ, Enders LR, Fortune A, Cain S, Vatinno AA, Schuster E, Ramakrishnan V, Feng W. Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors. Transl Stroke Res. 2020 Apr;11(2):204-213. doi: 10.1007/s12975-019-00724-9. Epub 2019 Aug 23.

  PMID: 31444692 DERIVED

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Na Jin Seo, PhD
• Organization: MUSC

seon@musc.edu

8437920084

Study Officials

• Na Jin Seo, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to the conditions, since they will not perceive any vibration for both conditions. The researcher conducting the evaluations with participants will also be blinded with the following procedure: A person outside the university will generate a random condition assignment sequence and send a custom program to the researcher to use.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will use a 2×2 crossover design. Participants will be randomly assigned to either the treatment or control condition for the first month, followed by a 2-week washout period and then crossover to the other condition.

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: October 23, 2017
• Study Start: January 9, 2018
• Primary Completion: October 22, 2018
• Study Completion: November 28, 2018
• Last Updated: May 7, 2019
• Results First Posted: March 6, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will become available within 1 year from the study completion date for 6 years.
• Access Criteria: De-identified data only

Locations

US (1)