NCT02587234

Brief Summary

The investigators proposed to evaluate the effectiveness of sustained peripheral nerve stimulation (PNS) to enhance the therapeutic effects of a modified form CIT (mCIT).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 stroke

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_1 stroke

Status
completed

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

November 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 14, 2017

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

3.3 years

First QC Date

October 23, 2015

Results QC Date

June 16, 2017

Last Update Submit

September 8, 2023

Conditions

StrokeCerebrovascular Accident

Keywords

motor recoverychronichumansensoryafferent inputmotor training

Outcome Measures

Primary Outcomes (1)

  • Change in Wolf Motor Function Test (WMFT), Timed Portion

    Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline

    baseline, post-intervention, 1-month follow-up

Secondary Outcomes (2)

  • Change in Fugl Meyer Assessment Motor Score

    baseline, post-intervention, 1-month follow-up

  • Change in Action Research Arm Test (ARAT)

    baseline, post-intervention, 1-month follow-up

Study Arms (2)

Active

EXPERIMENTAL

2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training

Device: peripheral nerve stimulation

Sham PNS

SHAM COMPARATOR

2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training

Device: peripheral nerve stimulation

Interventions

peripheral nerve stimulationDEVICE

Non-invasive stimulation of median, ulnar and radial nerves

ActiveSham PNS

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic stroke patients
  • Single stroke
  • Chronic (more than 12 months after from stroke)
  • At least 21 years old, but there is no upper age range for this project.
  • Participants must be able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.

You may not qualify if:

  • History of carpal tunnel syndrome and conditions that commonly cause peripheral neuropathy, including diabetes, uremia, or associated nutritional deficiencies
  • History of head injury with loss of consciousness, severe alcohol or drug abuse, psychiatric illness
  • Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
  • Cognitive deficit severe enough to preclude informed consent
  • Positive pregnancy test or being of childbearing age and not using appropriate contraception
  • Participants with history of untreated depression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Carrico C, Chelette KC 2nd, Westgate PM, Salmon-Powell E, Nichols L, Sawaki L. Randomized Trial of Peripheral Nerve Stimulation to Enhance Modified Constraint-Induced Therapy After Stroke. Am J Phys Med Rehabil. 2016 Jun;95(6):397-406. doi: 10.1097/PHM.0000000000000476.

    PMID: 26945226DERIVED

MeSH Terms

Conditions

StrokeBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Results Point of Contact

Title
Lumy Sawaki, MD, PhD
Organization
University of Kentucky
lumy.sawaki@uky.edu

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 27, 2015

Study Start

November 1, 2006

Primary Completion

February 1, 2010

Study Completion

April 1, 2012

Last Updated

September 13, 2023

Results First Posted

July 14, 2017

Record last verified: 2023-09