Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder

Neuromyelitis Optica Spectrum Disorder Clinical Trial

— aNiMatO  

Official title:

A Single Arm, Prospective, Multi-Center, Feasibility Study to Evaluate the Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder (NMOSD) Who Have an Impaired Gait

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06374264
• Other study ID #: NM100
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: MedRhythms, Inc.
• Contact: Cecilia Carlowicz, MPH
• Phone: 207-200-4482
• Email: ccarlowicz[@]medrhythms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) who have a gait deficit.

Description:

This is a single arm, prospective, multi-center feasibility study designed to evaluate the acceptability and safety of MR-C-014.

MR-C-014 is an autonomous neurorehabilitation system based on the principles of Rhythmic Auditory Stimulation (RAS) and is designed to operate digitally and autonomously. The core mechanism of RAS is "auditory-motor entrainment." Studies have shown that there is rich connectivity between the auditory and motor systems via multiple cortical and subcortical networks.

The MR-C-014 system consists of two foot sensors that measure walking, a locked touchscreen device preloaded with a proprietary software application, a headset, and charging equipment. The electronic components are powered by lithium-ion rechargeable batteries.

MR-C-014 is an investigational device.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age 18-70 years of age (inclusive).

2. Able to read and/or understand English.

3. Meets revised diagnostic criteria for NMOSD proposed by the International Panel for NMO Diagnosis (IPND) in 2015.

4. Past clinical history of Transverse Myelitis as seen on imaging or as determined by clinical review by the investigator.

5. Demonstrates an observable gait deficit resulting from a diagnosis of NMOSD as determined by the Investigator or medical history review.

6. Currently able to walk at a speed greater or equal to 0.4 m/s, but less than 1.0 m/s, as determined by walking speed during a Timed 25-Foot Walk Test (T25FWT) (cane(s), walking stick(s), crutch(es), wheeled walker, external functional neuromuscular stimulator(s), and ankle foot orthosis allowed).

a. Note: if assistive devices are planned to be used during the Intervention Phase walking sessions, they should be used during the Screening, Baseline, and Closing visit gait assessments as well.

7. Has a reciprocal gait pattern.

a. Note: a non-reciprocal gait pattern is defined as a 3-point step pattern. Participants must have a 2-point step pattern to qualify. Asymmetry seen in gait is acceptable.

8. Ability and willingness to provide Informed Consent.

Exclusion Criteria:

1. Unable or unwilling to comply with study protocol.

2. People who become pregnant or are pregnant (due to expected changes in gait patterns).

3. Unable to safely participate in protocol-defined walking sessions of 30-minute duration as determined by the investigator.

4. Significant co-morbid medical or neurological disease or injury, or treatment for such conditions that currently affects, or has potential to affect, participant gait for safety during participation in the study as determined by the investigator.

5. Has an external lower limb prosthetic ("artificial limb").

6. Initiated physical therapy for lower limb in the past 4 weeks or anticipated to start due to safety concerns (e.g., falls).

7. Requires at least one seated rest during the T25FWT.

8. Initiation, change, or discontinuation of disease-modifying therapy in the past 3 months known to affect gait (e.g., dalfampridine, corticosteroid, medications for spasticity).

9. Recent NMOSD relapse (last 3 months) and/or hospitalization.

10. Severe hearing impairment with or without the use of hearing aids, such that the participant cannot hear the rhythmic music stimulus consistently, as determined by participant and investigator.

11. Treatment with a gait-based investigational intervention within the last 3 months. Enrollment in observational studies is allowed.

12. Vulnerable populations as deemed inappropriate for study by investigator. For this protocol, vulnerable persons are considered to be those who are relatively (or absolutely) incapable of protecting their own interests.

Related Conditions & MeSH terms

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder

Intervention

Device:
• MR-C-014
Use of device 3 times per week (for 30 minutes) for 8 weeks - for a total of 24 sessions.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
MedRhythms, Inc.	Alexion Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spatiotemporal symmetry of gait as measured by the MR-C-014 sensors	Assesses spatiotemporal symmetry of gait in NMOSD patients with a gait deficit while using MR-C-014	Baseline and closing (up to 8 weeks)
Other	Spatiotemporal variability of gait as measured by the MR-C-014 sensors	Assesses spatiotemporal variability of gait in NMOSD patients with a gait deficit while using MR-C-014	Baseline and closing (up to 8 weeks)
Other	Stride length as measured by the MR-C-014 sensors	Assesses stride length in NMOSD patients with a gait deficit while using MR-C-014	Baseline and closing (up to 8 weeks)
Other	Falls Efficacy Scale-International (FES-I)	A 16-item self-administered questionnaire designed to assess fear of falling in mainly community-dwelling older population. Minimum score = 16 (no concern about falling); maximum score = 64 (severe concern about falling).	Baseline and closing (up to 8 weeks)
Other	Number of falls as recorded in Falls Diary	Assesses number of falls in NMOSD patients with a gait deficit	Weekly for up to 8 weeks
Other	Multiple Sclerosis Walking Scale (MSWS-12)	A self-report measure of the impact of MS on the individual's walking ability. Minimum score = 12 (not at all impacted); maximum score = 60 (extremely impacted).	Baseline and closing (up to 8 weeks)
Other	Visual Analogue Scale (VAS)	A validated, subjective measure to assess pain intensity. Minimum score = 0 (no pain); maximum score = 10 (worst pain possible).	Baseline and closing (up to 8 weeks)
Other	Generalized Anxiety Disorder-7 (GAD-7)	A self-administered patient questionnaire used as a screening tool and severity measure for generalized anxiety disorder. Minimum score = 0 (no anxiety); maximum score = 21 (severe anxiety).	Baseline and closing (up to 8 weeks)
Other	9 Hole Peg Test (9-HPT)	A standardized, quantitative assessment used to measure finger dexterity (time in seconds).	Baseline and closing (up to 8 weeks)
Other	Symbol Digit Modalities Test (SDMT)	A measure of cognitive processing speed. Minimum score = 0; maximum score = 110. Higher score indicates faster processing speed.	Baseline and closing (up to 8 weeks)
Other	Fatigue Scale for Motor and Cognitive Functions (FSMC)	A 20-item scale developed as a measure of cognitive and motor fatigue for people with MS. Minimum score = 20; maximum score = 100. Higher score indicates higher level of fatigue.	Baseline and closing (up to 8 weeks)
Other	Expanded Disability Status Scale (EDSS) Ambulation Score	The EDSS is a scale for assessing the level of disability in people with multiple sclerosis The ambulation score specifically assesses impairment to ambulation. Minimum score = 0; maximum score = 10. Higher score indicates greater disability.	Baseline and closing (up to 8 weeks)
Other	Activities-Specific Balance Confidence Scale (ABC)	A self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Minimum score = 0 (no confidence); maximum score = 100 (complete confidence).	Baseline and closing (up to 8 weeks)
Other	Patient Experience and Satisfaction Survey	Assesses patient satisfaction with the MR-C-014 device	Closing (at up to 8 weeks)
Primary	Participant acceptability of MR-C-014	Assesses participant engagement via logged use of MR-C-014	Intervention period (of up to 8 weeks)
Primary	Number of device-related adverse events (AEs)	Assesses the safety of MR-C-014 in NMOSD patients with a gait deficit	Weekly for up to 8 weeks
Secondary	6-Minute Walk Test (6MWT)	Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance (distance in meters)	Baseline and closing (up to 8 weeks)
Secondary	Number of walks per week	Assesses adherence to recommended frequency of MR-C-014 use. Recommended frequency is 3 walks per week for 8 weeks.	Weekly for up to 8 weeks