The Cortical Motor Effects of PNS and AO on Motor Training in Chronic Stroke
The Motor Effects of Combined Peripheral Nerve Electrical Stimulation and Action Observation on the Affected Hand in People With Stroke
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jun 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2015
CompletedFirst Submitted
Initial submission to the registry
June 28, 2018
CompletedFirst Posted
Study publicly available on registry
August 10, 2018
CompletedAugust 10, 2018
August 1, 2018
11 months
June 28, 2018
August 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
90 minutes
Secondary Outcomes (1)
Hand dexterity of paretic hand evaluated with Purdue Pegboard
24 hours
Study Arms (3)
PNS+AO+Training
EXPERIMENTALadopted "PNS+AO+Training" as the intervention
PNS+AOsham+Training
EXPERIMENTALadopted "PNS+AOsham+Training" as the intervention
PNSsham+AOsham+Training
PLACEBO COMPARATORadopted "PNSsham+AOsham+Training" as the intervention
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 28, 2018
First Posted
August 10, 2018
Study Start
June 23, 2014
Primary Completion
June 1, 2015
Study Completion
June 30, 2015
Last Updated
August 10, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share