Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury

NCT04130295 | Completed

• 1 other identifier: 787
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Spasticity is muscle spasms, bouncing (clonus) or stiffness that can negatively impact the quality of life of people with spinal cord injury (SCI). In people with spinal cord injury, spasticity can limit muscle control of the arms and hands and cause pain, discomfort, and frustration. Transcutaneous electrical stimulation has been shown to reduce spasticity after SCI. However, this type of stimulation's effects during prolonged, at-home use has not been well studied. Additionally, traditional stimulation techniques are often only available in the clinic. Therefore, this study aims to identify if wearable intensive nerve stimulation decreases spasticity in the legs of people with SCI, and if this intervention is usable and desirable to individuals with SCI.

Conditions

Spinal Cord Injuries; Spasticity, Muscle

Outcome Measures

Primary Outcomes (3)

• Change in Spasticity

  Instrumented Pendulum Test: Participants will be in a semi-reclined position on a therapy mat. The examiner will then bring the participants knee into full extension before dropping the foot. The examiner will observe the number of oscillations to determine muscle stretch-induced activity

  Week 1, Week 2, Week 3, and Week 7

• Satisfaction and Adherence Questionnaire

  Participant will answer questions about how likely they would be to continue to use the intervention at home.

  Week 7

• Spinal Cord Injury - Spasticity Evaluation Tool

  a Questionnaire used to characterize the impact of spasticity on a participant's ability to perform everyday occupations.

  Twice per week

Secondary Outcomes (7)

• Manual Ankle Clonus Test

  Week 1, Week 2, Week 3, and Week 7

• Ankle Drop Test

  Week 1, Week 2, Week 3, and Week 7

• Flexor Spasms

  Week 1, Week 2, Week 3, and Week 7

• Instrumented Flexor Reflex Response

  Week 1, Week 2, Week 3, and Week 7

• Global Impression of Change Scale

  Week 1, Week 2, Week 3, and Week 7

Study Arms (1)

Wearable intensive nerve stimulation

EXPERIMENTAL

The device will be worn on the upper calf with each session of stimulation lasting 60 minutes after which the device will turn off for 60 minutes before turning back on. Participants will be instructed to wear the device for 5 hours a day in order to receive three one our sessions of stimulation.

Other: Wearable intensive nerve stimulator

Interventions

Wearable intensive nerve stimulator OTHER

The wearable device consists of 2 leads that provide biphasic, with alternating lead phase, asymmetrical rectangular current at a pulse duration of 0.28 msec, a randomly varying pulse frequency between 60-100 Hz, with a maximum intensity of 100mA.

Wearable intensive nerve stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18-65 years of age
• Have sustained cervical or thoracic SCI at least 6 months prior to initiating participation in study
• Any ISNCSCI severity classification (A, B, C, or D)
• Have self-reported spasticity and at the time of screening demonstrate an FSE angle of ≤ 75 degrees on the pendulum test or ≥ 4 beats of clonus on the drop test
• May participate if utilizing oral prescription medications for control of spasticity
• Ability and willingness to consent and authorize use of personal health information

You may not qualify if:

• Severe contractures of the leg/foot to be stimulated (decided during pre-assessment) that limit passive movement of the hip, knee, or ankle more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol
• Any implanted catheter such as but not limited to CSF shunt, baclofen pump, or the presence of a pacemaker, implanted automatic internal cardioverter defibrillator (AICD, other cardiac implants and or conditions)
• Severe pain or hypersensitivity of the leg to be stimulated (decided during pre-assessment)
• Uncontrolled edema of the leg to be stimulated (decided during pre-assessment)
• Current pregnancy
• Lumbar spinal cord injury level
• Inability or unwillingness to consent and authorize use of personal health information

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead
• Emory University: collaborator

Study Sites (1)

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Muscle Spasticity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 17, 2019
• Study Start: October 15, 2019
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-03

Locations

US (1)