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The Cortical Motor Effects of PNS and AO on Motor Training in Chronic Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PNS+AO+Training
PNS+AOsham+Training
PNSsham+AOsham+Training
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Electrical Stimulation, Cortical Excitability, Transcranial Magnetic Stimulation

Eligibility Criteria

43 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 40 and 80 years;
  • has history of first hemispheric stroke of 6or more months;
  • presence of electromyographic signals in first dorsal interosseous (FDI) during active abduction of the index finger contralateral to the lesioned hemisphere;
  • medically stable;
  • able to comprehend instructions.

Exclusion Criteria:

  • past history of musculoskeletal or neurological impairment in the paretic upper limb;
  • recurrent stroke;
  • cognitive impairment (Mini-mental state examination (MMSE) < 24);
  • visual impairment not correctable by optical lens;
  • presence of metal in the head region or a cardiac pacemaker as contraindications for TMS (Rossi et al., 2009).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    PNS+AO+Training

    PNS+AOsham+Training

    PNSsham+AOsham+Training

    Arm Description

    adopted "PNS+AO+Training" as the intervention

    adopted "PNS+AOsham+Training" as the intervention

    adopted "PNSsham+AOsham+Training" as the intervention

    Outcomes

    Primary Outcome Measures

    Corticomotor excitability evoked by Transcranial magnetic stimulation (TMS)
    Corticomotor excitability in terms of the slope of the MEP recruitment curve and peak MEP amplitude captured for the contralateral FDI hand muscle in both hemispheres were assessed.

    Secondary Outcome Measures

    Hand dexterity of paretic hand evaluated with Purdue Pegboard
    The score was the total number of pins inserted into the holes with paretic hand in 30 seconds.

    Full Information

    First Posted
    June 28, 2018
    Last Updated
    August 8, 2018
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03625804
    Brief Title
    The Cortical Motor Effects of PNS and AO on Motor Training in Chronic Stroke
    Official Title
    The Motor Effects of Combined Peripheral Nerve Electrical Stimulation and Action Observation on the Affected Hand in People With Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 23, 2014 (Actual)
    Primary Completion Date
    June 1, 2015 (Actual)
    Study Completion Date
    June 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aimed to investigate if peripheral nerve stimulation (PNS) paired with action observation (AO) would augment motor training in promoting corticomotor excitability for the paretic hand in people with stroke. Twenty subjects in chronic stage of stroke were exposed to 3 different interventions involving one-hour PNS or sham PNS paired with 30 minutes of AO or sham AO, all followed by 30 minutes of finger abduction training in 3 separate sessions.
    Detailed Description
    The investigator's previous study (Liu & Au-Yeung, 2017; PMID: 28383292) has demonstrated that 1-hour peripheral nerve stimulation (PNS) applied to the radial and ulnar nerves of the paretic UL of people with chronic stroke can increase transcranial magnetic stimulation (TMS)-evoked excitability of corticomotor pathways in both hemispheres projected to the contralateral first dorsal interosseous (FDI) hand muscle, and also improve dexterity in the paretic hand. This bi-hemispheric effect of PNS suggests that certain additional therapies such as action observation (AO) and motor training should be incorporated to strengthen the plastic corticomotor adaptation specifically for paretic UL control. The hypothesis of this study is that PNS paired with AO would augment task training of the paretic hand by increasing the corticomotor excitability in the lesioned hemisphere for the trained hand muscle in people with stroke, with associated dexterity function improvement. Twenty subjects were recruited by convenience in the community. They then attended an assessment session to evaluate the baseline sensorimotor status of their paretic upper limb. After the clinical tests,the subjects were introduced the assessment procedure for measuring corticomotor excitability with transcranial magnetic stimulation (TMS). After 1-week intermission, the subjects returned for 3 intervention sessions with different protocols including (1)PNS+AO+Training; (2)PNS+AOsham+Training; and (3)PNSsham+AOsham+Training. These 3 intervention sessions were arranged in random sequence for subjects. For "PNS+AO+Training" session, electrical stimulation was applied to the radial and ulnar nerve (PNS) of the paretic arm for 60 minutes. During the last 30 minutes of PNS, action observation (AO) was introduced in which subjects were required to watch a series of video clips. After one hour's PNS+AO, the subjects then proceeded to a 30-minute period of motor training of paretic hand. During "PNS+AOsham+Training" session, PNS was given as described before. During the last 30 minutes of the PNS, subjects were shown different photos illustrating a letter, a number or a hand as AOsham. The protocol of motor training was the same as described before. In the session of "PNSsham+AOsham+Training", The 1-hour PNSsham was conducted with the electrical stimulation unit turned on but without current output. The protocols for AOsham and motor training were the same as those described before.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Electrical Stimulation, Cortical Excitability, Transcranial Magnetic Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Single-blind randomized cross-over study
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PNS+AO+Training
    Arm Type
    Experimental
    Arm Description
    adopted "PNS+AO+Training" as the intervention
    Arm Title
    PNS+AOsham+Training
    Arm Type
    Experimental
    Arm Description
    adopted "PNS+AOsham+Training" as the intervention
    Arm Title
    PNSsham+AOsham+Training
    Arm Type
    Placebo Comparator
    Arm Description
    adopted "PNSsham+AOsham+Training" as the intervention
    Intervention Type
    Genetic
    Intervention Name(s)
    PNS+AO+Training
    Intervention Description
    Electrical stimulation was applied to the radial and ulnar nerve (PNS) of the paretic arm for 60 minutes. During the last 30 minutes of PNS, action observation (AO) was introduced in which subjects were required to watch a series of video clips. After one hour's PNS+AO, the subjects then proceeded to a 30-minute period of motor training of paretic hand.
    Intervention Type
    Genetic
    Intervention Name(s)
    PNS+AOsham+Training
    Intervention Description
    PNS was given as described before. During the last 30 minutes of the PNS, subjects were shown different photos illustrating a letter, a number or a hand as AOsham. The protocol of motor training was the same as described before.
    Intervention Type
    Genetic
    Intervention Name(s)
    PNSsham+AOsham+Training
    Intervention Description
    The 1-hour PNSsham was conducted with the electrical stimulation unit turned on but without current output. The protocols for AOsham and motor training were the same as those described before.
    Primary Outcome Measure Information:
    Title
    Corticomotor excitability evoked by Transcranial magnetic stimulation (TMS)
    Description
    Corticomotor excitability in terms of the slope of the MEP recruitment curve and peak MEP amplitude captured for the contralateral FDI hand muscle in both hemispheres were assessed.
    Time Frame
    90 minutes
    Secondary Outcome Measure Information:
    Title
    Hand dexterity of paretic hand evaluated with Purdue Pegboard
    Description
    The score was the total number of pins inserted into the holes with paretic hand in 30 seconds.
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    43 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age between 40 and 80 years; has history of first hemispheric stroke of 6or more months; presence of electromyographic signals in first dorsal interosseous (FDI) during active abduction of the index finger contralateral to the lesioned hemisphere; medically stable; able to comprehend instructions. Exclusion Criteria: past history of musculoskeletal or neurological impairment in the paretic upper limb; recurrent stroke; cognitive impairment (Mini-mental state examination (MMSE) < 24); visual impairment not correctable by optical lens; presence of metal in the head region or a cardiac pacemaker as contraindications for TMS (Rossi et al., 2009).

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Cortical Motor Effects of PNS and AO on Motor Training in Chronic Stroke

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