ENROLLING_BY_INVITATION

ExaStim Upper Limb Home Use Clinical Validation Study

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Conditions

Cervical Spinal Cord InjuryNeuromodulationSpinal Cord TherapyRehabilitationElectrical Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multi-center, observational, single-arm, 6-week home study to evaluate the safety and efficacy of transcutaneous spinal cord stimulation via the ExaStim system for 4 consecutive weeks used in the home setting for individuals with traumatic spinal cord injury. The study consists of a baseline evaluation and 1-week training period (Week 0), a 4-week stimulation period (Weeks 1-4), and a follow-up visit (Week 5), for a total expected duration of participation for each subject of six weeks.

Official Title

ExaStim Upper Limb Home Use Clinical Validation Study

Quick Facts

Study Start:2025-03-17
Study Completion:2025-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT06850363

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject must have completed the ASPIRE clinical trial.
  2. 2. Subject must be ≥ 22 years of age at the time of the screening examination
  3. 3. Subject must have a traumatic, chronic\* spinal cord injury between C2 and T2 inclusive
  4. 4. Subject must have American Spinal Injury Association (ASIA) Impairment Scale A, B, C, or D via the ISNCSCI exam
  5. 5. Subject must have limited function of upper extremities with ISNCSCI Upper Extremity Motor Score for each arm from 5 to 20 inclusive
  6. 6. Subject must have a non-zero score in least one of the UEMS C7, C8 and T1 muscles on either side
  7. 7. Subject must have regular availability of a caregiver and/or family member to assist with donning and doffing the device and to assist with completion of session-related report forms
  8. 8. Subject, caregiver, and/or family member must be available for all in-clinic study visits and adhere to the study protocol
  9. 9. Subject, caregiver and/or family member must be able to use a digital mobile device, have reliable access to internet, and be able to complete all study related forms and questionnaires
  10. 10. Subject and caregiver must be able to commit to participating in a six-week study, be willing to comply with study instructions, agree to make all office and telehealth appointments, engage in a minimum of 12-minutes of home activities with stimulation per week, and complete the entire course of the study
  11. 11. Subject must be a primary/fluent English speaker
  12. 12. Subject must be able and willing to read, comprehend and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent
  1. 1. Active implanted medical device for electrical stimulation
  2. 2. Other internal metallic objects of unknown or foreign origin (unidentifiable surgical implants, shrapnel, bullet fragments, etc.)
  3. 3. Botox injections to the upper limb in prior 6 months
  4. 4. Uncontrolled autonomic dysreflexia or orthostatic hypotension
  5. 5. BMI \> 40.0 (morbid obesity)
  6. 6. Acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds, unhealed bone fractures, peripheral neuropathies or painful musculoskeletal dysfunction
  7. 7. Subjects who are pregnant or planned pregnancy during the study. Note: Subjects of childbearing potential must agree to the use an effective contraceptive for the duration of the study.
  8. 8. Allergy to hydrogel, silicone, latex or other product materials
  9. 9. Compromised skin in the area for electrode contact (back of neck and/or hip area)
  10. 10. Uncontrolled cardiopulmonary disease
  11. 11. Ventilator dependency
  12. 12. Uncontrolled epilepsy or seizures
  13. 13. Unmanaged depression, psychiatric disorders or ongoing substance abuse
  14. 14. Participation in another clinical trial that may interfere with this study

Contacts and Locations

Study Locations (Sites)

Craig Rehabilitation Hospital
Denver, Colorado, 80113
United States
TryAbility Neurorecovery Center
Downer Grove, Illinois, 60515
United States
Internation Center for Spinal Cord Injury at the Kennedy Krieger Institute
Baltimore, Maryland, 21205
United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02138
United States
Marquette University Neuro Recovery Clinic
Milwaukee, Wisconsin, 53233
United States

Collaborators and Investigators

Sponsor: Niche Biomedical, Inc. dba ANEUVO

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-17
Study Completion Date2025-10-30

Study Record Updates

Study Start Date2025-03-17
Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

  • Neuromodulation
  • Spinal Cord Therapy
  • Rehabilitation
  • Electrical Stimulation

Additional Relevant MeSH Terms

  • Cervical Spinal Cord Injury