Neuromodulation of Ankle Muscles in Persons With SCI

NCT ID: NCT04238013

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-06
• Study Completion Date: 2021-07-09

Brief Summary

The ability to voluntarily move the ankles is important for walking. After spinal cord injury (SCI), this ability is impaired because of changes in the communication between the brain, spinal cord, and body. Whole body vibration (WBV) is a treatment that increases voluntary muscle control and decreases uncontrollable muscle movement in people with SCI. The purpose of this study is to understand how WBV can impact ankle control and uncontrollable muscle movement.

Detailed Description

Spinal cord injury can result in impaired walking ability and decreased independence in daily activities such as standing and transfers. The ability to voluntarily control the ankle muscles is an important component of walking that is impacted by changes in the corticospinal tract and the spinal reflex circuits. These changes have been associated with the inability to dorsiflex the ankle during swing phase (foot drop) and uncontrollable muscle spasms and stiffness in the ankle during terminal stance (spasticity), as well as during transfers. In order to improve functional outcomes and further develop rehabilitation techniques, the underlying contributions of the corticospinal tract and spinal reflex circuit to ankle control needs to be better understood. Non-invasive tools that target the corticospinal and spinal reflex circuit are being used in clinical settings in order to improve functional outcomes in persons with spinal cord injury. Whole body vibration (WBV) is a non-invasive tool that has been shown to increase voluntary motor output and decrease spasticity in persons with spinal cord injury. These improvements in function may be due to changes in the corticospinal tract and spinal reflex circuits. In order to determine the relative contributions of the corticospinal tract and spinal reflex circuits to increased voluntary ankle control and decreased spasticity, we will measure changes in the corticospinal tract and spinal reflex excitability before and after a single session of vibration. We will then determine which change (corticospinal or spinal) contributes more to increased voluntary ankle control and decreased spasticity. This information will help guide future research to further improve walking ability in persons with spinal cord injury.

Conditions

Spinal Cord Injuries; Spastic Gait; Foot Drop

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Corticospinal Tract Excitability

During the Corticospinal Tract Excitability arm, corticospinal excitability will be assessed by measuring motor evoked potentials after transcranial magnetic stimulation pre-post each intervention in conjunction with other outcome measures.

Group Type: ACTIVE_COMPARATOR

Whole Body Vibration (WBV)

Intervention Type: OTHER

The WBV session will consist of 8 bouts of 45s vibration (50Hz) with a minute of rest in between each bout.

Electrical Stimulation

Intervention Type: OTHER

The electrical stimulation intervention serves to account for any effects of standing and/or of repeated performance of the sit-to-stand behavior on neurophysiological outcomes. In the electrical stimulation intervention, participants will receive electrical stimulation while standing on the vibration platform for 8 bouts for 45s with a minute of rest in between without vibration.

Spinal Reflex Circuit Excitability

During the Spinal Reflex Circuit Excitability arm, spinal reflex circuit excitability will be assessed by measuring low frequency depression after Hoffmann-Reflex testing pre-post each intervention in conjunction with other outcome measures.

Group Type: ACTIVE_COMPARATOR

Whole Body Vibration (WBV)

Intervention Type: OTHER

The WBV session will consist of 8 bouts of 45s vibration (50Hz) with a minute of rest in between each bout.

Electrical Stimulation

Intervention Type: OTHER

The electrical stimulation intervention serves to account for any effects of standing and/or of repeated performance of the sit-to-stand behavior on neurophysiological outcomes. In the electrical stimulation intervention, participants will receive electrical stimulation while standing on the vibration platform for 8 bouts for 45s with a minute of rest in between without vibration.

Interventions

Whole Body Vibration (WBV)

The WBV session will consist of 8 bouts of 45s vibration (50Hz) with a minute of rest in between each bout.

Intervention Type: OTHER

Electrical Stimulation

The electrical stimulation intervention serves to account for any effects of standing and/or of repeated performance of the sit-to-stand behavior on neurophysiological outcomes. In the electrical stimulation intervention, participants will receive electrical stimulation while standing on the vibration platform for 8 bouts for 45s with a minute of rest in between without vibration.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Ability and willingness to consent and authorize use of Protected Health Information (PHI)
• Be between 18-85 years of age
• Be able to provide a letter of medical clearance for participation, if 70-85 years of age
• Have a SCI level of T12 of above, occurring more than 6 months ago
• Have a motor-incomplete severity classification (AIS C OR D)
• Have self-reported spasticity in at least one ankle
• Have a score of at least 2 indicating at least moderate spasticity on the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) clonus test in at least one ankle
• Have the ability to voluntarily move at least one ankle
• Must be able to stand and take at least 4 steps with or without assistive devices

Exclusion Criteria

• Implanted metallic device in the head and/ or pacemaker
• Use of ankle-foot orthoses
• History of seizures
• History of frequent and/ or severe headaches
• Prior tendon or nerve transfer surgery
• Current pregnancy
• Inability or unwillingness to consent and Authorization for use of PHI
• Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
• Neurologic level below spinal level T12
• History of cardiovascular irregularities
• Problems with following instructions
• Orthopedic problems that would limit participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees).
• Active infection of any type, as infection may exacerbate spasticity resulting in inability to identify the influence of the treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Shepherd Center, Atlanta GA

OTHER

Sponsor Role: lead

Responsible Party

Edelle Field-Fote, PT, PhD

Director, Spinal Injury Research & The Hulse Spinal Injury Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edelle Field-Fote, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Director of Spinal Cord Injury Research

Locations

Shepherd Center

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

F31HD101151

Identifier Type: NIH

Identifier Source: secondary_id

View Link

777

Identifier Type: -

Identifier Source: org_study_id