StrokeNCT03625804
The Cortical Motor Effects of PNS and AO on Motor Training in Chronic Stroke
A study testing PNS+AO+Training in people with Stroke, run by The Hong Kong Polytechnic University.
Trial 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. Read more about this study
- Who is it for?
- Ages 43 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- PNS+AO+Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2014to 30 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 43 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: The Motor Effects of Combined Peripheral Nerve Electrical Stimulation and Action Observation on the Affected Hand in People With Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- PNS+AO+Training, PNS+AOsham+Training, PNSsham+AOsham+Training
- Keywords
- Electrical Stimulation, Cortical Excitability, Transcranial Magnetic Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNS+AO+TrainingGenetic
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+AOsham+TrainingGenetic
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.
PNSsham+AOsham+TrainingGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| PNS+AO+Training | Experimental | adopted "PNS+AO+Training" as the intervention Receives: Genetic: PNS+AO+Training |
| PNS+AOsham+Training | Experimental | adopted "PNS+AOsham+Training" as the intervention Receives: Genetic: PNS+AOsham+Training |
| PNSsham+AOsham+Training | Placebo comparator | adopted "PNSsham+AOsham+Training" as the intervention Receives: Genetic: PNSsham+AOsham+Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 minutes
Secondary outcomes (1)
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start23 Jun 2014
- Primary completion1 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-blind randomized cross-over study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIU Hao, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625804
- Sponsor's protocol ID
- HSEARS20140617001-01
- Status last verified
- Aug 2018
- First submitted
- 28 Jun 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Motor Effects of Combined Peripheral Nerve Electrical Stimulation and Action Observation on the Affected Hand in People With Stroke
- ClinicalTrials.gov ID
- NCT03625804
- Acronym / sponsor ID
- HSEARS20140617001-01
- Conditions
- Stroke
- Keywords
- Electrical Stimulation, Cortical Excitability, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 23 Jun 2014 (actual)
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single-blind randomized cross-over study
| Arm | Type | Receives |
|---|---|---|
| PNS+AO+Training | Experimental | Genetic: PNS+AO+Trainingadopted "PNS+AO+Training" as the intervention |
| PNS+AOsham+Training | Experimental | Genetic: PNS+AOsham+Trainingadopted "PNS+AOsham+Training" as the intervention |
| PNSsham+AOsham+Training | Placebo comparator | Genetic: PNSsham+AOsham+Trainingadopted "PNSsham+AOsham+Training" as the intervention |
Who may qualify
- Ages
- 43 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNS+AO+TrainingElectrical 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. | Genetic | PNS+AO+Training |
| PNS+AOsham+TrainingPNS 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. | Genetic | PNS+AOsham+Training |
| PNSsham+AOsham+TrainingThe 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. | Genetic | PNSsham+AOsham+Training |
Primary outcome
Corticomotor excitability evoked by Transcranial magnetic stimulation (TMS)
Time frame: 90 minutes
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.
1 secondary outcome
Hand dexterity of paretic hand evaluated with Purdue Pegboard
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PNS+AO+Training in people with Stroke, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corticomotor excitability evoked by Transcranial magnetic stimulation (TMS) (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.