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Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy

M

MyndTec

Status

Completed

Conditions

Spinal Cord Injuries
Trauma, Nervous System

Treatments

Device: MyndMove®
Other: Conventional Therapy

Study type

Interventional

Funder types

Other
Industry
Other U.S. Federal agency

Identifiers

NCT03439319
MM-SCI-4002
CDMRP-SC150251 (Other Grant/Funding Number)

Details and patient eligibility

About

A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy in the treatment of patients with moderate to severe motor impairment to their arms and hands from an incomplete, traumatic spinal cord injury.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Traumatic incomplete (AIS B-D) C4-C7 spinal cord injury
  2. Paralysis or paresis in both upper extremities
  3. At least 4 months (120 days) and less than 96 months (2,920 days) post traumatic SCI
  4. Baseline SCIM-SC ≤ 10
  5. From an inpatient or outpatient care setting
  6. Able to understand and follow instructions
  7. Able to tolerate being in a seated position for a least one hour required to deliver upper limb therapy
  8. Willing to attend treatment sessions and all assessment sessions
  9. Able to understand and provide informed consent
  10. Male and female participants ≥ 18 years of age at the time of enrollment

Exclusion criteria

  1. Previous history of any other neuromuscular disorder or conditions that may affect motor response
  2. Upper extremity injury or condition prior to SCI that limits the function of the hand or arm
  3. Malignant skin lesion on the affected upper extremity
  4. Rash or open wound at any potential electrode site
  5. History of seizure disorder not effectively managed by seizure medications
  6. An implanted metallic part (e.g. plates, screws or joint replacement) or electrical device (e.g. Implantable Cardiac Defibrillator, Pacemaker, Spinal Stimulation). (Note: If the participant has passive metallic implants, the therapy can be delivered if the implants are located in an area other than where the electrical stimulant is to be delivered.)
  7. Complete denervation of muscles that are targeted by MyndMove such that MyndMove is unable to elicit tetanic muscle contraction when upper limits of stimulation intensity for the targeted muscle are applied
  8. Poorly controlled autonomic dysreflexia (as determined by the local site physician)
  9. History of psychiatric illness requiring hospitalization within the past 24 months
  10. Active drug treatment for dementia
  11. Life expectancy of less than 12 months due to other illness
  12. In the judgment of the medical provider, the participant has medical complications that may interfere with the execution of the study
  13. Currently enrolled in another upper limb study and/ or has received MyndMove Therapy within the past 3 months
  14. Enrolled, in the past six months, in a clinical study involving drugs or biologics
  15. Currently dependent on a ventilator
  16. Botulinum toxin injection into affected upper extremity and the muscle targeted by MyndMove® therapy within 6 months prior to the study start. No botulinum toxin injections in the upper extremity during the study treatment and follow up period
  17. Females who are pregnant or planning to become pregnant in the duration of the trial
  18. Regional disorder of the upper extremities such as fracture, dislocation, or joint contractures to less than 50% of the expected range of motion

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

51 participants in 2 patient groups

MyndMove® therapy
Active Comparator group
Description:
Non-invasive Functional Electrical Stimulation (FES) technique with surface electrodes to stimulate from 3 to 8 muscles to create purposeful movements in one or both hands/arms
Treatment:
Device: MyndMove®
Intensive Conventional therapy
Active Comparator group
Description:
Using Conventional therapy which focuses exclusively on the purposeful movements in one or both hands/arms
Treatment:
Other: Conventional Therapy

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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