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
About this trial
This is an interventional treatment trial for Stroke focused on measuring Electrical Stimulation, Cortical Excitability, Transcranial Magnetic Stimulation
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).
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
NCT ID
NCT03625804
First Posted
June 28, 2018
Last Updated
August 8, 2018
Sponsor
The Hong Kong Polytechnic University
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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