Spinal Cord Stimulation to Augment Activity Based Therapy

NCT03240601 | Completed Results FDA Device

• 1 other identifier: 696
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Involuntary muscle activity, often called spasticity, is a common problem following spinal cord injury (SCI) that can make it hard to move. Many things can cause spasticity including: muscle stretch, movement, or it can happen for no reason, and it is often described as an uncontrolled muscle spasm or feeling of stiffness. Drugs are typically used to treat spasticity, but they often have side effects, like muscle weakness, which can add to movement problems. Rehabilitation therapies offer alternatives to drugs for treating involuntary muscle activity, and rehabilitation can also improve daily function and quality of life. These benefits may be greater when several rehabilitation therapies are used together. Walking ability can be improved with a type of therapy called "locomotor training". This type of therapy may also have the benefit of decreasing spasticity. When locomotor training (LT) is combined with electrical stimulation, the benefits of training may be increased. In this study, investigators will use a kind of stimulation called transcutaneous spinal cord stimulation ("TSS") to stimulate participants' spinal cord nerves during locomotor training.

Conditions

Transcutaneous Spinal Stimulation; Walking; Spasticity; Human; Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• Change in Walking Function - 10m Walk Walking Speed (m/s)

  You will walk over a mat that contains sensors to measure your walking speed as well as wear motion tracking sensors. You will be allowed to use whatever assistive devices you typically use (e.g., braces, walker, forearm crutches). In addition to walking speed, we will also assess your gait kinematics.

  Change in 10m Walk Speed (m/s) during the Intervention Phase (Week 2 test to Week 4 test)

• Change in Spasticity - Pendulum Test

  This test measures the amount of spasticity in your leg muscles. You will sit at the edge of a mat with your lower legs hanging over the edge of the mat. Motion capture sensors (Xsens) will be placed on both of your legs to record changes in your knee joint angles when your leg is dropped. The examiner will straighten your leg and then allow it to drop and swing over the edge of the mat. The angle of your knee and the movement of your leg will be recorded as it drops. This will be performed three times for each leg separately.

  Pendulum angle (degrees) change during the Intervention Phase (Week 2 test to Week 4 test)

Secondary Outcomes (5)

• Change in Walking Function - 2 Minute Walk

  2 Minute Walk test (distance) change during the Intervention Phase (Week 2 test to Week 4 test)

• Change in Spasticity - Ankle Clonus Drop Test

  Change in number of clonic ankle oscillations elicited via Ankle Clonus Drop Test during the Intervention Phase (Week 2 test to Week 4 test)

• Change in Spasticity - Muscle Co-contraction During Voluntary Activation

  Co-contraction change during the Intervention Phase (Week 2 test to Week 4 test)

• Change in Spasticity - Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) Test

  SCATS scores change during the Intervention Phase (Week 2 test to Week 4 test)

• Stimulation Tolerability

  Numerical rating scale of painfulness of stimulation in stimulation group only during stimulation weeks only (weeks 3 and 4)

Study Arms (2)

Subthreshold

SHAM COMPARATOR

Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will briefly ramp up to the lowest intensity that is first detected by the participant and then ramped down to a level no longer detected by the participant. Participants will continue their locomotor training.

Device: Transcutaneous spinal stimulation

Active

EXPERIMENTAL

Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will ramp up slowly to a level that produces parasthesia (tingling) throughout the lower extremity. This intensity will be applied for 30 minutes while participants continue their locomotor training.

Device: Transcutaneous spinal stimulation

Interventions

Transcutaneous spinal stimulation DEVICE

For TSS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz.

Also known as: TSS

Active; Subthreshold

Eligibility Criteria

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

You may qualify if:

• Ability and willingness to consent and/or authorize use of protected health information
• Be between 18-65 years of age
• Be enrolled in Spinal Cord Injury In-Patient or Day Program at the Shepherd Center
• Be eligible for locomotor training at the Shepherd Center
• Be able to take a step, with or without an assistive device
• Have a spinal cord injury, completed in-patient rehabilitation, and have been discharged to home
• Have at least mild "spasticity" affecting leg muscles
• You may participate if you use prescription medications, including baclofen for control of spasticity

You may not qualify if:

• Inability or unwillingness to consent and/or authorization for use of protected health information
• Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
• Neurologic level at or below spinal level T12
• History of cardiovascular irregularities
• Problems with following instructions
• Orthopedic problems that would limit your participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees)
• Women who are pregnant, or who have reason to believe they are or may become pregnant due to unknown risks to the fetus associated with tcSCS
• Persons who have implanted stimulators/electronic devices of any type will be excluded due to unknown potential of tcSCS effects
• Active infection of any type, as infection may exacerbate spasticity resulting in inability to identify the influence of the treatment

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead
• Foundation Wings For Life: collaborator

Study Sites (1)

Shepherd Center, Inc.

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Muscle Spasticity; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Edelle Field-Fote
• Organization: Shepherd Center

edelle.field-fote@shepherd.org

4046034274

Study Officials

• Edelle C Field-Fote, PT, PhD

  Shepherd Center, Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: August 7, 2017
• Study Start: July 1, 2017
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: January 25, 2022
• Results First Posted: January 25, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)