Trial Outcomes & Findings for TheraBracelet Phase I (NCT NCT03318341)
NCT ID: NCT03318341
Last Updated: 2019-05-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Two 1-month durations
Results posted on
2019-05-07
Participant Flow
Participant milestones
| Measure |
Real Then Sham
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.
|
Sham Then Real
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.
|
|---|---|---|
|
Month 1
STARTED
|
13
|
13
|
|
Month 1
COMPLETED
|
13
|
12
|
|
Month 1
NOT COMPLETED
|
0
|
1
|
|
Month 2
STARTED
|
13
|
12
|
|
Month 2
COMPLETED
|
13
|
12
|
|
Month 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TheraBracelet Phase I
Baseline characteristics by cohort
| Measure |
Real Then Sham
n=13 Participants
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.
|
Sham Then Real
n=13 Participants
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
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 11 • n=5 Participants
|
58 years
STANDARD_DEVIATION 10 • n=7 Participants
|
60 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two 1-month durationsAny 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.
Outcome measures
| Measure |
Real Then Sham
n=13 Participants
Receive real stimulation for 1 month, then sham stimulation for 1 month.
|
Sham Then Real
n=12 Participants
Receive sham stimulation for 1 month, then real stimulation for 1 month.
|
|---|---|---|
|
Safety - Occurrence of Device-Related Adverse Events (AE)
AE Month 1
|
2 Participants
|
4 Participants
|
|
Safety - Occurrence of Device-Related Adverse Events (AE)
AE Month 2
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Two 1-month durationsOutcome measures
| Measure |
Real Then Sham
n=13 Participants
Receive real stimulation for 1 month, then sham stimulation for 1 month.
|
Sham Then Real
n=12 Participants
Receive sham stimulation for 1 month, then real stimulation for 1 month.
|
|---|---|---|
|
Feasibility - User Compliance in Wearing the Device
Compliance Month 1
|
13 Participants
|
12 Participants
|
|
Feasibility - User Compliance in Wearing the Device
Compliance Month 2
|
13 Participants
|
12 Participants
|
Adverse Events
Real Then Sham - Month 1 (Real)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Sham Then Real - Month 1 (Sham)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Real Then Sham - Month 2 (Sham)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Sham Then Real - Month 2 (Real)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Real Then Sham - Month 1 (Real)
n=13 participants at risk
Receive real stimulation for month 1
|
Sham Then Real - Month 1 (Sham)
n=12 participants at risk
Receive sham stimulation for month 1
|
Real Then Sham - Month 2 (Sham)
n=13 participants at risk
Receive sham stimulation for month 2.
|
Sham Then Real - Month 2 (Real)
n=12 participants at risk
Receive real stimulation month 2.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin surgery
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected for 2.5 month study period.
|
0.00%
0/12 • Adverse event data were collected for 2.5 month study period.
|
0.00%
0/13 • Adverse event data were collected for 2.5 month study period.
|
0.00%
0/12 • Adverse event data were collected for 2.5 month study period.
|
|
General disorders
Transient ischemic attack-like symptoms
|
0.00%
0/13 • Adverse event data were collected for 2.5 month study period.
|
16.7%
2/12 • Number of events 2 • Adverse event data were collected for 2.5 month study period.
|
0.00%
0/13 • Adverse event data were collected for 2.5 month study period.
|
0.00%
0/12 • Adverse event data were collected for 2.5 month study period.
|
Other adverse events
| Measure |
Real Then Sham - Month 1 (Real)
n=13 participants at risk
Receive real stimulation for month 1
|
Sham Then Real - Month 1 (Sham)
n=12 participants at risk
Receive sham stimulation for month 1
|
Real Then Sham - Month 2 (Sham)
n=13 participants at risk
Receive sham stimulation for month 2.
|
Sham Then Real - Month 2 (Real)
n=12 participants at risk
Receive real stimulation month 2.
|
|---|---|---|---|---|
|
General disorders
Temporary feeling of numbness or worsening in sensory scores
|
23.1%
3/13 • Number of events 6 • Adverse event data were collected for 2.5 month study period.
|
25.0%
3/12 • Number of events 22 • Adverse event data were collected for 2.5 month study period.
|
15.4%
2/13 • Number of events 3 • Adverse event data were collected for 2.5 month study period.
|
41.7%
5/12 • Number of events 10 • Adverse event data were collected for 2.5 month study period.
|
|
Musculoskeletal and connective tissue disorders
Temporary reduction in grip strength
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected for 2.5 month study period.
|
0.00%
0/12 • Adverse event data were collected for 2.5 month study period.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected for 2.5 month study period.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected for 2.5 month study period.
|
|
General disorders
Temporary increase in Modified Ashworth scale scores
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected for 2.5 month study period.
|
0.00%
0/12 • Adverse event data were collected for 2.5 month study period.
|
0.00%
0/13 • Adverse event data were collected for 2.5 month study period.
|
0.00%
0/12 • Adverse event data were collected for 2.5 month study period.
|
|
General disorders
Temporary increase in pain
|
0.00%
0/13 • Adverse event data were collected for 2.5 month study period.
|
16.7%
2/12 • Number of events 2 • Adverse event data were collected for 2.5 month study period.
|
0.00%
0/13 • Adverse event data were collected for 2.5 month study period.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected for 2.5 month study period.
|
|
Skin and subcutaneous tissue disorders
Temporary skin irritation
|
23.1%
3/13 • Number of events 4 • Adverse event data were collected for 2.5 month study period.
|
8.3%
1/12 • Number of events 3 • Adverse event data were collected for 2.5 month study period.
|
15.4%
2/13 • Number of events 4 • Adverse event data were collected for 2.5 month study period.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected for 2.5 month study period.
|
|
General disorders
Temporary swelling
|
0.00%
0/13 • Adverse event data were collected for 2.5 month study period.
|
0.00%
0/12 • Adverse event data were collected for 2.5 month study period.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected for 2.5 month study period.
|
25.0%
3/12 • Number of events 5 • Adverse event data were collected for 2.5 month study period.
|
|
General disorders
Other
|
15.4%
2/13 • Number of events 3 • Adverse event data were collected for 2.5 month study period.
|
0.00%
0/12 • Adverse event data were collected for 2.5 month study period.
|
15.4%
2/13 • Number of events 2 • Adverse event data were collected for 2.5 month study period.
|
8.3%
1/12 • Number of events 2 • Adverse event data were collected for 2.5 month study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place