Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06320444 |
Recruitment Status :
Recruiting
First Posted : March 20, 2024
Last Update Posted : March 20, 2024
|
Tracking Information | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date | December 19, 2022 | ||||||||||||
First Posted Date | March 20, 2024 | ||||||||||||
Last Update Posted Date | March 20, 2024 | ||||||||||||
Actual Study Start Date | June 15, 2023 | ||||||||||||
Estimated Primary Completion Date | December 15, 2024 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures |
|
||||||||||||
Original Primary Outcome Measures | Same as current | ||||||||||||
Change History | No Changes Posted | ||||||||||||
Current Secondary Outcome Measures | Not Provided | ||||||||||||
Original Secondary Outcome Measures | Not Provided | ||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title | Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease | ||||||||||||
Official Title | Developing Novel Non-invasive Electrophysiological Biomarkers of Dysfunction in Spinal and Cortical Pathways and Sensorimotor Impairments in Motor Neurone Disease | ||||||||||||
Brief Summary | Substantial variability exists in the onset, and rate of degeneration across individuals with Motor Neurone Disease (MND) or Amyotrophic Lateral Sclerosis (ALS). This variability requires biomarkers that accurately classify and reliably track clinical subtypes as the disease progresses. Degeneration occurs in the brain and spinal cord, however, non-invasive diagnosis of spinal cord function remains highly challenging due to its unique alignment in spine. Disruption of complex spinal and cortical circuits that transmit and process neural signals for position sense and movement has not been adequately captured in the neurophysiological profiling of ALS patients. The overarching aim of this study is to reveal and quantify the extent of change in the sensorimotor integration and its potential contribution to network disruption in ALS. | ||||||||||||
Detailed Description | Background: Substantial variability exists in the onset, and rate of degeneration across individuals with Motor Neurone Disease (MND) or Amyotrophic Lateral Sclerosis (ALS). This variability requires biomarkers that accurately classify and reliably track clinical subtypes as the disease progresses. Degeneration occurs in the brain and spinal cord, however, non-invasive diagnosis of spinal cord function remains highly challenging due its unique alignment in the spine. Disruption of complex spinal and cortical circuits that transmit and process neural signals for position sense and movement has not been adequately captured in the neurophysiological profiling of ALS patients. Aim: To develop, test, and employ non-invasive techniques to explore (dys)function between motor, sensory brain, and spinal networks in ALS. The project will address if the electrical activity of the cortical-spinal network by the of use peripheral stimulation (vibration, electrical nerve stimulation) to probe and reveal the normal or abnormal communication between brain and spinal networks. It is expected to reveal novel neurophysiological signatures in ALS patients compared to healthy controls. Study Design & Data Analysis: Surface electrodes will be mounted over the targeted regions in conjunction with High-Density EEG and High-density Electromyography (EMG). A physical and mathematical model of the underlying sources of electric activity (source localization) will be carried out at rest, during task, and with non-invasive peripheral nerve stimulation (PNS) and TMS. A separate paradigm will augment sensorimotor communication between the primary motor cortex (M1) and the somatosensory cortex (S1). Mild vibration (5N/< 500 grams) will be applied to the wrist and/or bicep tendon transcutaneously. Vibration in conjunction with non-invasive peripheral nerve stimulation will induce transient changes (30 seconds maximum) in the intrinsic excitability of motor neurons in the spinal cord. Surface EMG will capture altered MN activity at the spinal level and the anticipated augmented communication in cortical networks (S1-M1) will be captured with EEG through connectivity analysis. Non-invasive transcranial magnetic stimulation in conjunction with vibration/nerve stimulation will be recorded to explore upper motor neurone influences on the altered intrinsic excitability of spinal motor neurons. Data collection: EXG-EEG-EMG and TMS/Peripheral Stimulation recordings will be conducted using a BioSemi® ActiveTwo system with 128 active sintered Ag-AgCl electrodes and headcaps (BioSemi B.V., Amsterdam, The Netherlands). The TMS system is a Brainbox DuoMAG (Brainbox Ltd., Cardif, Wales, UK) which can be used with a Digitimer peripheral stimulator. |
||||||||||||
Study Type | Observational | ||||||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||||||
Target Follow-Up Duration | Not Provided | ||||||||||||
Biospecimen | Not Provided | ||||||||||||
Sampling Method | Non-Probability Sample | ||||||||||||
Study Population | Healthy controls and patients diagnosed with ALS, MS, PLS, PMA, and SMA. | ||||||||||||
Condition |
|
||||||||||||
Intervention | Procedure: 232 Electrode Electrophysiology (EEG-ECG-EMG-EXG)
Noninvasive 232 Channel Electrode Electrophysiological signals (EEG-ECG-EMG-EXG) will be recorded from electrodes placed in a montage over the scalp, neck,and upper back along with muscles located on the hand. These signals will be recorded while resting or performing voluntary task. Other Intervention: The 232 electrode noninvasive electrophysiological data will be recorded in response to non-invasive peripheral nerve stimulation or vibration induced stimulation. These sessions are designed to engage specific cortical motor networks of interest for evaluating sensorimotor networks. (Cognitive, behavioural, motor, spinal, and sensory) Other Names:
|
||||||||||||
Study Groups/Cohorts |
|
||||||||||||
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 | Recruiting | ||||||||||||
Estimated Enrollment |
240 | ||||||||||||
Original Estimated Enrollment | Same as current | ||||||||||||
Estimated Study Completion Date | July 15, 2025 | ||||||||||||
Estimated Primary Completion Date | December 15, 2024 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria | Inclusion Criteria: - Healthy Volunteers:
Patients:
Exclusion Criteria: - Healthy Controls:
Patients:
|
||||||||||||
Sex/Gender |
|
||||||||||||
Ages | 18 Years and older (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers | Yes | ||||||||||||
Contacts |
|
||||||||||||
Listed Location Countries | Ireland | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number | NCT06320444 | ||||||||||||
Other Study ID Numbers | CRFSJ0297 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product |
|
||||||||||||
IPD Sharing Statement |
|
||||||||||||
Current Responsible Party | Orla Hardiman, University of Dublin, Trinity College | ||||||||||||
Original Responsible Party | Same as current | ||||||||||||
Current Study Sponsor | University of Dublin, Trinity College | ||||||||||||
Original Study Sponsor | Same as current | ||||||||||||
Collaborators |
|
||||||||||||
Investigators |
|
||||||||||||
PRS Account | University of Dublin, Trinity College | ||||||||||||
Verification Date | March 2024 |