NCT04576013

Brief Summary

Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2016

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

5 years

First QC Date

September 29, 2020

Last Update Submit

February 23, 2021

Conditions

Stroke

Keywords

neuroplasticityrehabilitationperipheral nerve stimulationmotor training

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment

    This is a quantitative measure of motor recovery, coordination, and speed.

    Baseline, Immediately post-intervention

Secondary Outcomes (3)

  • Action Research Arm Test

    Baseline, Immediately post-intervention

  • Stroke Impact Scale

    Baseline, Immediately post-intervention

  • Cortical motor map volume

    Baseline, Immediately post-intervention

Study Arms (3)

Active PNS during training

EXPERIMENTAL

Individuals in this group will receive active PNS while participating in 2 hours of motor training of the affected arm.

Device: Peripheral nerve stimulation (PNS)Behavioral: Intensive upper extremity motor training

Active PNS before training

ACTIVE COMPARATOR

Individuals in this group will receive 2 hours of active PNS before participating in 2 hours of motor training of the affected arm.

Device: Peripheral nerve stimulation (PNS)Behavioral: Intensive upper extremity motor training

Sham PNS during training

SHAM COMPARATOR

Individuals in this group will receive 2 hours of sham PNS while participating in 2 hours of motor training of the affected arm.

Device: Peripheral nerve stimulation (PNS)Behavioral: Intensive upper extremity motor training

Interventions

Peripheral nerve stimulation (PNS)DEVICE

Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.

Active PNS before trainingActive PNS during trainingSham PNS during training
Intensive upper extremity motor trainingBEHAVIORAL
Active PNS before trainingActive PNS during trainingSham PNS during training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have severe upper extremity motor deficit after a single stroke
  • Stroke onset at least 12 months ago

You may not qualify if:

  • Addition or change in the dosage of drugs known to exert detrimental effects on motor recovery within 3 months of enrollment
  • Untreated depression
  • History of multiple strokes
  • History of seizure
  • History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness
  • Positive pregnancy test or being of childbearing age and not using appropriate contraception
  • Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain
  • Cardiac or neural pacemakers or implanted medication pumps
  • Receptive aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky at Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 5, 2020

Study Start

February 23, 2016

Primary Completion

February 22, 2021

Study Completion

February 22, 2021

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations

US(1)