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Serial Fasciculation Measurements in Motor Neurone Disease

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ClinicalTrials.gov Identifier: NCT03809845
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Tracking Information
First Submitted Date  ICMJE March 13, 2018
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE July 6, 2017
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03809845 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Change in fasciculation morphology over time [ Time Frame: 12 months ]
  • Change in Functional Rating Scale (FRS) over time [ Time Frame: 12 months ]
    Maximum score of 48; lower scores indicate worse disability
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serial Fasciculation Measurements in Motor Neurone Disease
Official Title  ICMJE Sequential High-density Surface Electromyography (HDSEMG) Recordings in Motor Neurone Disease: Fasciculations as a Biomarker of Motor Neurone Health
Brief 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. 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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Condition  ICMJE
  • Motor Neuron Disease
  • Benign Fasciculation-Cramp Syndrome
Intervention  ICMJE Device: High-density surface electromyography
High-density surface electromyography
Study Arms  ICMJE
  • Active Comparator: Motor neuron disease
    Intervention: Device: High-density surface electromyography
  • Active Comparator: Benign fasciculation syndrome
    Intervention: Device: High-density surface electromyography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2019)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria for MND patients:

(i) Aged between 40 and 80 years of age inclusive, at the time of signing the informed consent.

(ii) 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.

(iii) 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:

(i) Aged between 18 and 80 years of age inclusive, at the time of signing the informed consent.

(ii) Diagnosed with BFS by a neurologist with expertise in motor nerve disorders.

(iii) 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).

Exclusion criteria for MND patients:

(i) Neurological (other than the subject's MND) or non-neurological co-morbidities (e.g. joint disease, respiratory disease) which limit mobility.

(ii) Clinically significant cognitive impairment in the opinion of the investigator or lacking capacity in accordance with the Mental Capacity Act (2005).

(iii) 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
  • MND or parkinsonism dementia complex (iv) Subjects requiring mechanical ventilation (non-invasive ventilation for sleep apnoea is allowed).

    (v) 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.

(vi) Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter-defibrillator) or at a high risk for needing external defibrillation.

(vii) 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:

(i) Significant diagnostic uncertainty, whereby motor neurone disease remains a possible differential diagnosis.

(ii) 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.

(iii) Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter-defibrillator) or at a high risk for needing external defibrillation.

(iv) 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809845
Other Study ID Numbers  ICMJE KCH17-105
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party King's College Hospital NHS Trust
Study Sponsor  ICMJE King's College Hospital NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account King's College Hospital NHS Trust
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP