Trial Outcomes & Findings for Vibrotactile Stimulation in Parkinson's Disease (NCT NCT02933476)

Results Overview

Questionnaire asks patients to record any adverse effects they experienced.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

1 Month

Results posted on

2018-01-23

Participant Flow

6 subjects were enrolled, but data only collected for 5 subjects. (1 subject was enrolled but no baseline data was collected due to illness)

Participant milestones

Participant milestones
Measure	Vibrotactile Stimulation Treatment All patients will receive the vibrotactile stimulation treatment. No deception will be used. Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vibrotactile Stimulation in Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vibrotactile Stimulation Treatment n=5 Participants All patients will receive the vibrotactile stimulation treatment. No deception will be used. Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Unified Parkinson's disease Rating Scale, Part III	21 units on a scale STANDARD_DEVIATION 12.8 • n=5 Participants
Disease Duration	5.718 years STANDARD_DEVIATION 2.694 • n=5 Participants

PRIMARY outcome

Timeframe: 1 Month

Questionnaire asks patients to record any adverse effects they experienced.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation Treatment n=5 Participants All patients will receive the vibrotactile stimulation treatment. No deception will be used. Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device.
Number of Patients Reporting Any Adverse Effects	0 Participants

SECONDARY outcome

Timeframe: 1 Month

We used the motor portion of the Unified Parkinson's disease Rating Scale (UPDRS) and excluded rigidity and speech from the assessment. Overall range of the score for the motor portion (excluding rigidity and speech) range from 0 to 108, where 0= best possible outcome and 108= worst possible outcome.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation Treatment n=5 Participants All patients will receive the vibrotactile stimulation treatment. No deception will be used. Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device.
Unified Parkinson's Disease Rating Scale, Part III UPDRS III at Baseline	21 units on a scale Standard Deviation 12.8
Unified Parkinson's Disease Rating Scale, Part III UPDRS III at 1 week from baseline	21.8 units on a scale Standard Deviation 11.7
Unified Parkinson's Disease Rating Scale, Part III UPDRS III at 4 weeks from baseline	20.8 units on a scale Standard Deviation 14.8

SECONDARY outcome

Timeframe: 1 Month

Population: One out of the five patients was on medication so was excluded from analysis.

Using gyroscopes to track patient movement testing, root mean square velocity (Vrms) of of the wrist during repetitive wrist flexion extension task was obtained.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation Treatment n=4 Participants All patients will receive the vibrotactile stimulation treatment. No deception will be used. Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device.
Root Mean Square Velocity Average Vrms at baseline	350.637 deg/s Standard Deviation 140.222
Root Mean Square Velocity Average Vrms at 1 month	456.736 deg/s Standard Deviation 156.634

SECONDARY outcome

Timeframe: 1 Month

Population: One out of the five patients was on medication so was excluded from analysis.

Using data collected from inertial measurement unit (IMU) sensors on subject, we were able to measure gait asymmetry. For each subject, the swing time (SW) was calculated and averaged across strides for the left and right legs (SWL and SWR). We obtained gait asymmetry using the following: 100 x /ln(SWR/SWL)/. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit.

Outcome measures

Outcome measures
Measure	Vibrotactile Stimulation Treatment n=4 Participants All patients will receive the vibrotactile stimulation treatment. No deception will be used. Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device.
Gait Asymmetry Average gait asymmetry at 1 month	4.53 arb.units Standard Deviation 5.51
Gait Asymmetry Average gait asymmetry at baseline	8.51 arb.units Standard Deviation 5.66

Adverse Events

Vibrotactile Stimulation Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raumin Neuville

Stanford School of Medicine

Phone: 6507236709

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place