Trial Outcomes & Findings for Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke (NCT NCT04026399)

Results Overview

motor evoked potential suppression by conditioning electrical stimulation

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

1 month

Results posted on

2021-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	Stimulation + Therapy The participant receives stimulation and home therapy. peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation. therapy: practice of daily living tasks	no Stimulation + Therapy The participant receives no stimulation and receives home therapy. therapy: practice of daily living tasks
Overall Study STARTED	6	6
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stimulation + Therapy n=6 Participants The participant receives stimulation and home therapy. peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation. therapy: practice of daily living tasks	no Stimulation + Therapy n=6 Participants The participant receives no stimulation and receives home therapy. therapy: practice of daily living tasks	Total n=12 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 12 • n=5 Participants	61 years STANDARD_DEVIATION 9 • n=7 Participants	61 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 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	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

motor evoked potential suppression by conditioning electrical stimulation

Outcome measures

Outcome measures
Measure	Stimulation + Therapy n=3 Participants The participant receives stimulation and home therapy. peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation. therapy: practice of daily living tasks	no Stimulation + Therapy n=2 Participants The participant receives no stimulation and receives home therapy. therapy: practice of daily living tasks
Short-latency Afferent Inhibition	48 % of unconditioned motor evoked potentia Standard Deviation 56	21 % of unconditioned motor evoked potentia Standard Deviation 35

SECONDARY outcome

Timeframe: 1 month

standardized clinical upper extremity function score

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

standardized patient-reported hand function assessment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

standardized patient-reported hand function assessment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

time of reactive force

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

time of reactive force

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

standardized clinical upper extremity function score

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

standardized clinical upper extremity function score

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

angle of the grip force vector from the normal direction

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

angle of the grip force vector from the normal direction

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

affected hand use amount as measured by accelerometers

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

affected hand use amount as measured by accelerometers

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

magnitude of reactive grip force

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

magnitude of reactive grip force

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

additional force used during grip

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

additional force used during grip

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

motor evoked potential amplitude

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

motor evoked potential amplitude

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

EEG spectral power perturbation during grip

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

EEG spectral power perturbation during grip

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

EEG coherence within the sensorimotor network

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

EEG coherence within the sensorimotor network

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

motor evoked potential suppression by conditioning electrical stimulation

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

number of blocks moved in a minute

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

number of blocks moved in a minute

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

standardized clinical upper extremity function score

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

standardized clinical upper extremity function score

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 month

standardized clinical upper extremity function score

Outcome measures

Outcome data not reported

Adverse Events

Stimulation + Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

no Stimulation + Therapy

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stimulation + Therapy n=6 participants at risk The participant receives stimulation and home therapy. peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation. therapy: practice of daily living tasks	no Stimulation + Therapy n=6 participants at risk The participant receives no stimulation and receives home therapy. therapy: practice of daily living tasks
Surgical and medical procedures gallbladder removal	0.00% 0/6 • 4 months	16.7% 1/6 • Number of events 1 • 4 months

Other adverse events

Other adverse events
Measure	Stimulation + Therapy n=6 participants at risk The participant receives stimulation and home therapy. peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation. therapy: practice of daily living tasks	no Stimulation + Therapy n=6 participants at risk The participant receives no stimulation and receives home therapy. therapy: practice of daily living tasks
Musculoskeletal and connective tissue disorders increased muscle tone	0.00% 0/6 • 4 months	16.7% 1/6 • Number of events 4 • 4 months

Additional Information

Na Jin Seo

Medical University of South Carolina

Phone: 8437920084

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place