Spinal Cord InjuriesNCT03254862
Different Stimulation Patterns to Reduce Muscle Fatigue During FES
A study testing CSS/AsynS and CSS/AsynR in people with Spinal Cord Injuries, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
The main aim of this study is to investigate the effect of patterned distribution stimulation compared to conventional stimulation in reducing muscle fatigue during functional electrical stimulation (FES) following spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- CSS/AsynS and CSS/AsynR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Aug 2017to 30 Jun 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- incomplete spinal cord injury
- able to give informed consent
- able to sit up in a chair
Who cannot join
- female subjects who are pregnant
- significant history of autonomic dysreflexia
- unable to give informed consent
- individuals who have a cardiac history
- individuals who have significant cognitive impairment
- individuals with muscular abnormality
Show all 10Show fewer
- individuals who have significant contractures in the lower extremities
- individuals who have a rash or infection at the site of electrode placement (gastrocnemius for both legs)
- individuals who are hypersensitive to electrical stimulation
- individuals who are presently involved in another study which has overlap with the methodology and/or outcomes of the studies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth National Spinal Injuries Unit
Glasgow
About this study
Official title: Investigation of Different Stimulation Patterns to Reduce Muscle Fatigue During Functional Electrical Stimulation (FES)
The main aim of this study is to investigate the effect of patterned distribution stimulation compared to conventional stimulation in reducing muscle fatigue during functional electrical stimulation (FES) following spinal cord injury (SCI).
Read the detailed description
Functional electrical stimulation (FES) is a commonly used technique in rehabilitation and often associated with rapid muscle fatigue which becomes the limiting factor in its applications. The main objective of this study is to investigate the effects on the onset of fatigue of conventional synchronous stimulation, as well as asynchronous stimulation that mimic voluntary muscle activation targeting different motor units which are activated sequentially or randomly via multiple pairs of stimulation electrodes. Three different approaches with various electrode configurations will be investigated, as well as different patterns of stimulation applied to the gastrocnemius muscle. In addition, the muscle changes during different patterns of stimulation will be evaluated in this study.
- Conditions
- Spinal Cord Injuries
- Being tested
- CSS/AsynS, CSS/AsynR
- Keywords
- Functional electrical stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSS/AsynSProcedure or surgery
16 sessions of training over a 4 week period consisting of repeated intermittent electrical stimulation (300ms On and 700ms Off stimulation) for 10 - 30 minutes. Conventional synchronous stimulation (CSS) on one leg; Asynchronous Sequential Stimulation (ASynS) on the other leg
CSS/AsynRProcedure or surgery
16 sessions of training over a 4 week period consisting of repeated intermittent electrical stimulation (300ms On and 700ms Off stimulation) for 10 - 30 minutes. Conventional synchronous stimulation (CSS) on one leg; Asynchronous Random Stimulation (ASynR) on the other leg.
| Study group | Role | What they receive |
|---|---|---|
| Group A: CSS & AsynS | Experimental | Electrical stimulation training on both legs:
Conventional synchronous stimulation (CSS) and Asynchronous Sequential Stimulation (ASynS) - CSS/ASynS Receives: Procedure: CSS/AsynS |
| Group B: CSS & AsynR | Experimental | Electrical stimulation training on both legs:
Conventional synchronous stimulation (CSS) and Asynchronous Random Stimulation (ASynR) - CSS/ASynR Receives: Procedure: CSS/AsynR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle contraction ability
Change in torque produced during muscle contraction
Measured: Baseline to 6 weeks
Secondary outcomes (3)
Normalized Fatigue Index (NFI)
Change in score on Normalized Fatigue Index (NFI)
Measured: Baseline to 6 weeks
Fatigue Time Interval (FTI)
Change in Fatigue Time Interval (FTI)
Measured: Baseline to 6 weeks
Twitch-Tetanus Ratio response (ΔTTR)
Change in Twitch-Tetanus Ratio response (ΔTTR)
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start14 Aug 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Why it stopped: Initial difficulties recruiting + main researcher had to withdraw from the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Henrik Gollee, DipIng PhD, Study director, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254862
- Sponsor's protocol ID
- GN17NE114
- Status last verified
- Sep 2018
- First submitted
- 16 Aug 2017
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Different Stimulation Patterns to Reduce Muscle Fatigue During Functional Electrical Stimulation (FES)
- ClinicalTrials.gov ID
- NCT03254862
- Acronym / sponsor ID
- GN17NE114
- Conditions
- Spinal Cord Injuries
- Keywords
- Functional electrical stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Initial difficulties recruiting + main researcher had to withdraw from the study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 21 Aug 2017 (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.
The main aim of this study is to investigate the effect of patterned distribution stimulation compared to conventional stimulation in reducing muscle fatigue during functional electrical stimulation (FES) following spinal cord injury (SCI).
Detailed description
Functional electrical stimulation (FES) is a commonly used technique in rehabilitation and often associated with rapid muscle fatigue which becomes the limiting factor in its applications. The main objective of this study is to investigate the effects on the onset of fatigue of conventional synchronous stimulation, as well as asynchronous stimulation that mimic voluntary muscle activation targeting different motor units which are activated sequentially or randomly via multiple pairs of stimulation electrodes. Three different approaches with various electrode configurations will be investigated, as well as different patterns of stimulation applied to the gastrocnemius muscle. In addition, the muscle changes during different patterns of stimulation will be evaluated in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: CSS & AsynS | Experimental | Procedure: CSS/AsynSElectrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Sequential Stimulation (ASynS) - CSS/ASynS |
| Group B: CSS & AsynR | Experimental | Procedure: CSS/AsynRElectrical stimulation training on both legs: Conventional synchronous stimulation (CSS) and Asynchronous Random Stimulation (ASynR) - CSS/ASynR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- incomplete spinal cord injury
- able to give informed consent
- able to sit up in a chair
Key exclusion criteria (10 listed)
- female subjects who are pregnant
- significant history of autonomic dysreflexia
- unable to give informed consent
- individuals who have a cardiac history
- individuals who have significant cognitive impairment
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 |
|---|---|---|
| CSS/AsynS16 sessions of training over a 4 week period consisting of repeated intermittent electrical stimulation (300ms On and 700ms Off stimulation) for 10 - 30 minutes. Conventional synchronous stimulation (CSS) on one leg; Asynchronous Sequential Stimulation (ASynS) on the other leg | Procedure or surgery | Group A: CSS & AsynS |
| CSS/AsynR16 sessions of training over a 4 week period consisting of repeated intermittent electrical stimulation (300ms On and 700ms Off stimulation) for 10 - 30 minutes. Conventional synchronous stimulation (CSS) on one leg; Asynchronous Random Stimulation (ASynR) on the other leg. | Procedure or surgery | Group B: CSS & AsynR |
Primary outcome
Muscle contraction ability
Time frame: Baseline to 6 weeks
Change in torque produced during muscle contraction
3 secondary outcomes
Normalized Fatigue Index (NFI)
Time frame: Baseline to 6 weeks
Fatigue Time Interval (FTI)
Time frame: Baseline to 6 weeks
Twitch-Tetanus Ratio response (ΔTTR)
Time frame: Baseline to 6 weeks
Results and safety
The study was stopped early (reason given: Initial difficulties recruiting + main researcher had to withdraw from the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Active, not recruitingPhase 1/2
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
Heterotopic Ossification (HO)
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Recruiting
Reticulospinal Control of Movements
Spinal Cord Injuries, Healthy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
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.
Henrik Gollee, DipIng PhD study director
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSS/AsynS and CSS/AsynR in people with Spinal Cord Injuries, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was stopped early (reason given: Initial difficulties recruiting + main researcher had to withdraw from the study). Results are not available in the source record.
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?
Muscle contraction ability (time frame: Baseline to 6 weeks). 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 7 Sep 2018.