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TheraBracelet Phase I

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ClinicalTrials.gov Identifier: NCT03318341
Recruitment Status : Completed
First Posted : October 23, 2017
Results First Posted : March 6, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
TheraBracelet, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hand Function
Stroke
Upper Extremity
Hemiparesis
Cerebrovascular Accident
Stroke Rehabilitation
Interventions Device: Real Stimulation
Device: Sham Stimulation
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Real Then Sham Sham Then Real
Hide Arm/Group Description

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 no stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.

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

Sham Stimulation: The device applies no vibration.

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 no 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.

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

Sham Stimulation: The device applies no vibration.

Period Title: Month 1
Started 13 13
Completed 13 12
Not Completed 0 1
Period Title: Month 2
Started 13 12
Completed 13 12
Not Completed 0 0
Arm/Group Title Real Then Sham Sham Then Real Total
Hide Arm/Group Description

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 no stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.

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

Sham Stimulation: The device applies no vibration.

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 no 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.

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

Sham Stimulation: The device applies no vibration.

Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
62  (11) 58  (10) 60  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
4
  30.8%
4
  30.8%
8
  30.8%
Male
9
  69.2%
9
  69.2%
18
  69.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Hispanic or Latino
1
   7.7%
1
   7.7%
2
   7.7%
Not Hispanic or Latino
12
  92.3%
12
  92.3%
24
  92.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  38.5%
6
  46.2%
11
  42.3%
White
7
  53.8%
6
  46.2%
13
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   7.7%
1
   7.7%
2
   7.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 26 participants
13 13 26
1.Primary Outcome
Title Safety - Occurrence of Device-Related Adverse Events (AE)
Hide Description 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.
Time Frame Two 1-month durations
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real Then Sham Sham Then Real
Hide Arm/Group Description:
Receive real stimulation for 1 month, then sham stimulation for 1 month.
Receive sham stimulation for 1 month, then real stimulation for 1 month.
Overall Number of Participants Analyzed 13 12
Measure Type: Count of Participants
Unit of Measure: Participants
AE Month 1
2
  15.4%
4
  33.3%
AE Month 2
0
   0.0%
1
   8.3%
2.Primary Outcome
Title Feasibility - User Compliance in Wearing the Device
Hide Description [Not Specified]
Time Frame Two 1-month durations
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real Then Sham Sham Then Real
Hide Arm/Group Description:
Receive real stimulation for 1 month, then sham stimulation for 1 month.
Receive sham stimulation for 1 month, then real stimulation for 1 month.
Overall Number of Participants Analyzed 13 12
Measure Type: Count of Participants
Unit of Measure: Participants
Compliance Month 1
13
 100.0%
12
 100.0%
Compliance Month 2
13
 100.0%
12
 100.0%
Time Frame Adverse event data were collected for 2.5 month study period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Real Then Sham - Month 1 (Real) Sham Then Real - Month 1 (Sham) Real Then Sham - Month 2 (Sham) Sham Then Real - Month 2 (Real)
Hide Arm/Group Description Receive real stimulation for month 1 Receive sham stimulation for month 1 Receive sham stimulation for month 2. Receive real stimulation month 2.
All-Cause Mortality
Real Then Sham - Month 1 (Real) Sham Then Real - Month 1 (Sham) Real Then Sham - Month 2 (Sham) Sham Then Real - Month 2 (Real)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)      0/12 (0.00%)      0/13 (0.00%)      0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Real Then Sham - Month 1 (Real) Sham Then Real - Month 1 (Sham) Real Then Sham - Month 2 (Sham) Sham Then Real - Month 2 (Real)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      2/12 (16.67%)      0/13 (0.00%)      0/12 (0.00%)    
General disorders         
Transient ischemic attack-like symptoms   0/13 (0.00%)  0 2/12 (16.67%)  2 0/13 (0.00%)  0 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders         
Skin surgery  [1]  1/13 (7.69%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Routine skin surgery for the past 30 years
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Real Then Sham - Month 1 (Real) Sham Then Real - Month 1 (Sham) Real Then Sham - Month 2 (Sham) Sham Then Real - Month 2 (Real)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/13 (61.54%)      6/12 (50.00%)      6/13 (46.15%)      7/12 (58.33%)    
General disorders         
Temporary feeling of numbness or worsening in sensory scores   3/13 (23.08%)  6 3/12 (25.00%)  22 2/13 (15.38%)  3 5/12 (41.67%)  10
Temporary increase in Modified Ashworth scale scores   1/13 (7.69%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0
Temporary increase in pain   0/13 (0.00%)  0 2/12 (16.67%)  2 0/13 (0.00%)  0 1/12 (8.33%)  1
Temporary swelling   0/13 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1 3/12 (25.00%)  5
Other   2/13 (15.38%)  3 0/12 (0.00%)  0 2/13 (15.38%)  2 1/12 (8.33%)  2
Musculoskeletal and connective tissue disorders         
Temporary reduction in grip strength   1/13 (7.69%)  1 0/12 (0.00%)  0 1/13 (7.69%)  1 1/12 (8.33%)  1
Skin and subcutaneous tissue disorders         
Temporary skin irritation   3/13 (23.08%)  4 1/12 (8.33%)  3 2/13 (15.38%)  4 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Na Jin Seo, PhD
Organization: MUSC
Phone: 8437920084
EMail: seon@musc.edu
Layout table for additonal information
Responsible Party: TheraBracelet, Inc.
ClinicalTrials.gov Identifier: NCT03318341     History of Changes
Other Study ID Numbers: 1R41HD090792-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 20, 2017
First Posted: October 23, 2017
Results First Submitted: January 4, 2019
Results First Posted: March 6, 2019
Last Update Posted: May 7, 2019