Motor Neuron DiseaseNCT03809845
Serial Fasciculation Measurements in Motor Neurone Disease
A study testing High-density surface electromyography in people with Motor Neuron Disease and Benign Fasciculation-Cramp Syndrome, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Patients with motor neurone disease (MND) typically experience relentless motor decline and die within three years of symptom onset from respiratory muscle weakness. There are currently no effective therapies and the discovery of novel therapies is hampered by the lack of a sensitive disease biomarker. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Motor Neuron Disease, Benign Fasciculation-Cramp Syndrome
- What is being tested?
- High-density surface electromyography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jul 2017to 1 Mar 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 40 and 80 years of age inclusive, at the time of signing the informed consent.
- Diagnosed with MND by a neurologist with expertise in MND.(20) For subjects with bulbar onset there must be objective limb involvement of at least one limb.
- Diagnosed with MND within 24 months of symptom onset. (iv) Subjects must be ambulatory (i.e. must not be confined to a wheelchair). (v) Male and female subjects (vi) Capable of giving signed informed consent (vii) Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance).
- Inclusion criteria for Benign Fasciculation Syndrome (BFS) patients:
- Aged between 18 and 80 years of age inclusive, at the time of signing the informed consent.
- Diagnosed with BFS by a neurologist with expertise in motor nerve disorders.
- Male and female subjects (vi) Capable of giving signed informed consent (vii) Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance).
Who cannot join
- Neurological (other than the subject's MND) or non-neurological co-morbidities (e.g. joint disease, respiratory disease) which limit mobility.
- Clinically significant cognitive impairment in the opinion of the investigator or lacking capacity in accordance with the Mental Capacity Act (2005).
- Regionally restricted forms of MND, or other atypical variants:
- Isolated corticobulbar pattern of MND with normal ambulation
- Primary lateral sclerosis
- Signs of chronic partial denervation restricted to a single limb
Show all 15Show fewer
- MND or parkinsonism dementia complex (iv) Subjects requiring mechanical ventilation (non-invasive ventilation for sleep apnoea is allowed).
- Historical or current evidence of clinically significant uncontrolled disease which, in the opinion of the chief investigator, would put the safety of the subject at risk through participation or impact the study assessments or endpoints.
- Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter-defibrillator) or at a high risk for needing external defibrillation.
- History of skin hypersensitivity to adhesives. (viii) Current participation in a clinical trial which in the opinion of the chief investigator might impact the objectives of this study.
- Exclusion criteria for Benign Fasciculation Syndrome patients:
- Significant diagnostic uncertainty, whereby motor neurone disease remains a possible differential diagnosis.
- Historical or current evidence of clinically significant uncontrolled disease which, in the opinion of the chief investigator, would put the safety of the subject at risk through participation or impact the study assessments or endpoints.
- Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter-defibrillator) or at a high risk for needing external defibrillation.
- History of skin hypersensitivity to adhesives. (v) Current participation in a clinical trial which in the opinion of the chief investigator might impact the objectives of this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London
About this study
Official title: Sequential High-density Surface Electromyography (HDSEMG) Recordings in Motor Neurone Disease: Fasciculations as a Biomarker of Motor Neurone Health
Patients with motor neurone disease (MND) typically experience relentless motor decline and die within three years of symptom onset from respiratory muscle weakness. There are currently no effective therapies and the discovery of novel therapies is hampered by the lack of a sensitive disease biomarker. Consequently, there is a huge drive to discover novel biomarkers, which can reliably track disease progression over time. These can then be incorporated into clinical drug trials to expedite effective drug discovery.
Muscle fasciculations represent the hyperexcitability of diseased motor neurons and are almost universally present from the early stages of MND. The investigators predict that the site, frequency and shape of fasciculations might provide a sensitive measure of disease progression in an individual.
In order to calibrate this technique, the investigators will conduct a 12-month longitudinal study, recruiting 24 patients from the King's College Hospital Motor Nerve Clinic, comprising a mixture of patients with MND and those with benign fasciculation syndrome. Patients in this latter group have fasciculations but do not develop weakness and have normal lifespans. They are therefore an optimal control group. At each visit, the investigators will take resting HDSEMG recordings from all four limbs and perform standard clinical measures of disease progression. The investigators will also monitor the decline in motor unit number using a newly validated neurophysiological technique, called Motor Unit Number Index (MUNIX).
- Being tested
- High-density surface electromyography
- Medical subject headings
- Motor Neuron Disease, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-density surface electromyographyDevice
High-density surface electromyography
| Study group | Role | What they receive |
|---|---|---|
| Motor neuron disease | Active comparator | Not described Receives: Device: High-density surface electromyography |
| Benign fasciculation syndrome | Active comparator | Not described Receives: Device: High-density surface electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasciculation frequency over time
To characterise the frequency of fasciculations in patients with motor neurone disease and to determine whether these parameters correlate with the trajectory of disease progression over a 12-month period.
Measured: 12 months
Secondary outcomes (5)
Change in fasciculation morphology over time
Measured: 12 months
Change in Functional Rating Scale (FRS) over time
Maximum score of 48; lower scores indicate worse disability
Measured: 12 months
Change in motor unit number index measurements over time
Measured: 12 months
Change in MRC power sum score over time
Measured: 12 months
Change in slow vital capacity over time
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start6 Jul 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Neuron DiseaseStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 20 Motor Neuron Disease (MND) patients and 5 Benign Fasciculation Syndrome (BFS) patients undergoing same assessments at 2-monthly intervals for one year
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809845
- Sponsor's protocol ID
- KCH17-105
- Status last verified
- Aug 2019
- First submitted
- 13 Mar 2018
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential High-density Surface Electromyography (HDSEMG) Recordings in Motor Neurone Disease: Fasciculations as a Biomarker of Motor Neurone Health
- ClinicalTrials.gov ID
- NCT03809845
- Acronym / sponsor ID
- KCH17-105
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 18 Jan 2019 (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.
Patients with motor neurone disease (MND) typically experience relentless motor decline and die within three years of symptom onset from respiratory muscle weakness. There are currently no effective therapies and the discovery of novel therapies is hampered by the lack of a sensitive disease biomarker. Consequently, there is a huge drive to discover novel biomarkers, which can reliably track disease progression over time. These can then be incorporated into clinical drug trials to expedite effective drug discovery.
Muscle fasciculations represent the hyperexcitability of diseased motor neurons and are almost universally present from the early stages of MND. The investigators predict that the site, frequency and shape of fasciculations might provide a sensitive measure of disease progression in an individual.
In order to calibrate this technique, the investigators will conduct a 12-month longitudinal study, recruiting 24 patients from the King's College Hospital Motor Nerve Clinic, comprising a mixture of patients with MND and those with benign fasciculation syndrome. Patients in this latter group have fasciculations but do not develop weakness and have normal lifespans. They are therefore an optimal control group. At each visit, the investigators will take resting HDSEMG recordings from all four limbs and perform standard clinical measures of disease progression. The investigators will also monitor the decline in motor unit number using a newly validated neurophysiological technique, called Motor Unit Number Index (MUNIX).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 20 Motor Neuron Disease (MND) patients and 5 Benign Fasciculation Syndrome (BFS) patients undergoing same assessments at 2-monthly intervals for one year
| Arm | Type | Receives |
|---|---|---|
| Motor neuron disease | Active comparator | Device: High-density surface electromyography |
| Benign fasciculation syndrome | Active comparator | Device: High-density surface electromyography |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 40 and 80 years of age inclusive, at the time of signing the informed consent.
- Diagnosed with MND by a neurologist with expertise in MND.(20) For subjects with bulbar onset there must be objective limb involvement of at least one limb.
- Diagnosed with MND within 24 months of symptom onset. (iv) Subjects must be ambulatory (i.e. must not be confined to a wheelchair). (v) Male and female subjects (vi) Capable of giving signed informed consent (vii) Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance).
- Aged between 18 and 80 years of age inclusive, at the time of signing the informed consent.
- Diagnosed with BFS by a neurologist with expertise in motor nerve disorders.
Key exclusion criteria (15 listed)
- Neurological (other than the subject's MND) or non-neurological co-morbidities (e.g. joint disease, respiratory disease) which limit mobility.
- Clinically significant cognitive impairment in the opinion of the investigator or lacking capacity in accordance with the Mental Capacity Act (2005).
- Regionally restricted forms of MND, or other atypical variants:
- Isolated corticobulbar pattern of MND with normal ambulation
- Primary lateral sclerosis
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 |
|---|---|---|
| High-density surface electromyographyHigh-density surface electromyography | Device | Benign fasciculation syndrome, Motor neuron disease |
Primary outcome
Change in fasciculation frequency over time
Time frame: 12 months
To characterise the frequency of fasciculations in patients with motor neurone disease and to determine whether these parameters correlate with the trajectory of disease progression over a 12-month period.
5 secondary outcomes
Change in fasciculation morphology over time
Time frame: 12 months
Change in Functional Rating Scale (FRS) over time
Time frame: 12 months
Change in motor unit number index measurements over time
Time frame: 12 months
Change in MRC power sum score over time
Time frame: 12 months
Change in slow vital capacity over time
Time frame: 12 months
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 21 Aug 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-density surface electromyography in people with Motor Neuron Disease and Benign Fasciculation-Cramp Syndrome, run by King's College Hospital NHS Trust 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 7 inclusion and 15 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 21 Aug 2019. 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 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?
Change in fasciculation frequency over time (time frame: 12 months). 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 21 Aug 2019.