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

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT04026399
• Collaborator: National Institute of General Medical Sciences (NIGMS) (NIH)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.3
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

More than 4 million stroke survivors in the U.S. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. Hand disability has a profound negative impact on functional ability and independence. One way to improve hand function is to use peripheral sensory stimulation. Sensory stimulation in conjunction with therapy has been shown to improve motor outcomes more than therapy alone. While promising, most modalities of sensory stimulation interfere with natural hand tasks. To address these practical limitations, we have developed a new stimulation, imperceptible random-frequency vibration applied to wrist skin via a watch. In this study, we will determine if use of this vibration increases hand functional recovery.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Physical Disability	Other: peripheral vibration stimulation; Behavioral: therapy	N/A

Detailed Description

The study design is a double-blinded randomized controlled study. Subjects will wear the device for at least 8 hours/day every day for a month, during which they will come to the laboratory for weekly evaluation. Follow-up evaluation will occur 3 months after. The device will deliver vibration (treatment) or no vibration (control).

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke
• Actual Study Start Date: Jul 8, 2019
• Actual Primary Completion Date: Oct 15, 2020
• Actual Study Completion Date: Oct 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: stimulation + therapy The participant receives stimulation and home therapy.	Other: peripheral vibration stimulation; wearing a wristband that delivers imperceptible vibratory stimulation.; Behavioral: therapy; practice of daily living tasks
Sham Comparator: no stimulation + therapy The participant receives no stimulation and receives home therapy.	Behavioral: therapy; practice of daily living tasks

Outcome Measures

Primary Outcome Measures

1. Short-latency Afferent Inhibition [1 month]

   motor evoked potential suppression by conditioning electrical stimulation

Secondary Outcome Measures

1. Action Research Arm Test [1 month]

   standardized clinical upper extremity function score

Other Outcome Measures

1. Stroke Impact Scale Hand Subscale [1 month]

   standardized patient-reported hand function assessment

2. Stoke Impact Scale Hand Subscale [4 month]

   standardized patient-reported hand function assessment

3. Timing of Reactive Force Generation Per Perturbation [1 month]

   time of reactive force

4. Timing of Reactive Force Generation Per Perturbation [4 month]

   time of reactive force

5. Fugl-Meyer Upper Limb Assessment [1 month]

   standardized clinical upper extremity function score

6. Fugl-Meyer Upper Limb Assessment [4 month]

   standardized clinical upper extremity function score

7. Grip Force Direction [1 month]

   angle of the grip force vector from the normal direction

8. Grip Force Direction [4 month]

   angle of the grip force vector from the normal direction

9. In-home Hand Use Amount [1 month]

   affected hand use amount as measured by accelerometers

10. In-home Hand Use Amount [4 month]

    affected hand use amount as measured by accelerometers

11. Reactive Force Magnitude Per Perturbation [1 month]

    magnitude of reactive grip force

12. Reactive Force Magnitude Per Perturbation [4 month]

    magnitude of reactive grip force

13. Safety Margin [1 month]

    additional force used during grip

14. Safety Margin [4 month]

    additional force used during grip

15. Corticomotor Excitability [1 month]

    motor evoked potential amplitude

16. Corticomotor Excitability [4 month]

    motor evoked potential amplitude

17. Spectral Power Perturbation During Grip [1 month]

    EEG spectral power perturbation during grip

18. Spectral Power Perturbation During Grip [4 month]

    EEG spectral power perturbation during grip

19. Connectivity [1 month]

    EEG coherence within the sensorimotor network

20. Connectivity [4 month]

    EEG coherence within the sensorimotor network

21. Short-latency Afferent Inhibition [4 month]

    motor evoked potential suppression by conditioning electrical stimulation

22. Box and Block Test [1 month]

    number of blocks moved in a minute

23. Box and Block Test [4 month]

    number of blocks moved in a minute

24. Wolf Motor Function Test [1 month]

    standardized clinical upper extremity function score

25. Wolf Motor Function Test [4 month]

    standardized clinical upper extremity function score

26. Action Research Arm Test [4 month]

    standardized clinical upper extremity function score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chronic stroke survivor (>= 6 months post stroke)

• Ability to move an object with the paretic hand

• Fingertip sensory deficits

• Ability to put on a watch daily (by oneself or with help)

Exclusion Criteria:

• Currently undergoing other upper extremity rehabilitation therapy

• Upper limb botulinum toxin within 3 months prior to or during enrollment

• Change in neurological disorder medications during the enrollment

• Complete upper limb deafferentation

• Rigidity (Modified Ashworth Scale=5)

• Brainstem stroke

• Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)

• Language barrier or cognitive impairment that precludes following instructions and/or providing consent

If a participant has contraindications for Transcranial Magnetic Stimulation (TMS), the participant will not do TMS.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Caorlina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina
• National Institute of General Medical Sciences (NIGMS)

Investigators

• Study Chair: Steven Kautz, PhD, Medical University of South Carolina

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 20, 2020
• Informed Consent Form - Apr 24, 2019

More Information

Publications

None provided.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT04026399
• Other Study ID Numbers: Pro00086207; P20GM109040
• First Posted: Jul 19, 2019
• Last Update Posted: Aug 23, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Medical University of South Carolina: physical stimulation; Subliminal stimulation; stroke rehabilitation; upper extremity; paresis; hand function; occupational therapy; physical therapy
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Stimulation + Therapy	no Stimulation + Therapy	Total
Arm/Group Description	The participant receives stimulation and home therapy. peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation. therapy: practice of daily living tasks	The participant receives no stimulation and receives home therapy. therapy: practice of daily living tasks	Total of all reporting groups
Overall Participants	6	6	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (12)	61 (9)	61 (10)
Sex: Female, Male (Count of Participants)
Female	2 33.3%	4 66.7%	6 50%
Male	4 66.7%	2 33.3%	6 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 50%	3 50%	6 50%
White	3 50%	2 33.3%	5 41.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 16.7%	1 8.3%
Region of Enrollment (participants) [Number]
United States	6 100%	6 100%	12 100%

Outcome Measures

1. Primary Outcome

Title	Short-latency Afferent Inhibition
Description	motor evoked potential suppression by conditioning electrical stimulation
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stimulation + Therapy	no Stimulation + Therapy
Arm/Group Description	The participant receives stimulation and home therapy. peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation. therapy: practice of daily living tasks	The participant receives no stimulation and receives home therapy. therapy: practice of daily living tasks
Measure Participants	3	2
Mean (Standard Deviation) [% of unconditioned motor evoked potentia]	48 (56)	21 (35)

2. Secondary Outcome

Title	Action Research Arm Test
Description	standardized clinical upper extremity function score
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Other Pre-specified Outcome

Title	Stroke Impact Scale Hand Subscale
Description	standardized patient-reported hand function assessment
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Other Pre-specified Outcome

Title	Stoke Impact Scale Hand Subscale
Description	standardized patient-reported hand function assessment
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Other Pre-specified Outcome

Title	Timing of Reactive Force Generation Per Perturbation
Description	time of reactive force
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Other Pre-specified Outcome

Title	Timing of Reactive Force Generation Per Perturbation
Description	time of reactive force
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

Title	Fugl-Meyer Upper Limb Assessment
Description	standardized clinical upper extremity function score
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Other Pre-specified Outcome

Title	Fugl-Meyer Upper Limb Assessment
Description	standardized clinical upper extremity function score
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Other Pre-specified Outcome

Title	Grip Force Direction
Description	angle of the grip force vector from the normal direction
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Other Pre-specified Outcome

Title	Grip Force Direction
Description	angle of the grip force vector from the normal direction
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Other Pre-specified Outcome

Title	In-home Hand Use Amount
Description	affected hand use amount as measured by accelerometers
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Other Pre-specified Outcome

Title	In-home Hand Use Amount
Description	affected hand use amount as measured by accelerometers
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Other Pre-specified Outcome

Title	Reactive Force Magnitude Per Perturbation
Description	magnitude of reactive grip force
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

14. Other Pre-specified Outcome

Title	Reactive Force Magnitude Per Perturbation
Description	magnitude of reactive grip force
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

15. Other Pre-specified Outcome

Title	Safety Margin
Description	additional force used during grip
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Other Pre-specified Outcome

Title	Safety Margin
Description	additional force used during grip
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

17. Other Pre-specified Outcome

Title	Corticomotor Excitability
Description	motor evoked potential amplitude
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

18. Other Pre-specified Outcome

Title	Corticomotor Excitability
Description	motor evoked potential amplitude
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

19. Other Pre-specified Outcome

Title	Spectral Power Perturbation During Grip
Description	EEG spectral power perturbation during grip
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

20. Other Pre-specified Outcome

Title	Spectral Power Perturbation During Grip
Description	EEG spectral power perturbation during grip
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

21. Other Pre-specified Outcome

Title	Connectivity
Description	EEG coherence within the sensorimotor network
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

22. Other Pre-specified Outcome

Title	Connectivity
Description	EEG coherence within the sensorimotor network
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

23. Other Pre-specified Outcome

Title	Short-latency Afferent Inhibition
Description	motor evoked potential suppression by conditioning electrical stimulation
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

24. Other Pre-specified Outcome

Title	Box and Block Test
Description	number of blocks moved in a minute
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

25. Other Pre-specified Outcome

Title	Box and Block Test
Description	number of blocks moved in a minute
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

26. Other Pre-specified Outcome

Title	Wolf Motor Function Test
Description	standardized clinical upper extremity function score
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

27. Other Pre-specified Outcome

Title	Wolf Motor Function Test
Description	standardized clinical upper extremity function score
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

28. Other Pre-specified Outcome

Title	Action Research Arm Test
Description	standardized clinical upper extremity function score
Time Frame	4 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	4 months
Arm/Group Title	Stimulation + Therapy		no Stimulation + Therapy
Arm/Group Description	The participant receives stimulation and home therapy. peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation. therapy: practice of daily living tasks		The participant receives no stimulation and receives home therapy. therapy: practice of daily living tasks
All Cause Mortality
	Stimulation + Therapy		no Stimulation + Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Serious Adverse Events
	Stimulation + Therapy		no Stimulation + Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		1/6 (16.7%)
Surgical and medical procedures
gallbladder removal	0/6 (0%)	0	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	Stimulation + Therapy		no Stimulation + Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		1/6 (16.7%)
Musculoskeletal and connective tissue disorders
increased muscle tone	0/6 (0%)	0	1/6 (16.7%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.