Neuromodulation of Ankle Muscles in Persons With SCI

NCT04238013 | Terminated

• 2 other identifiers: 777F31HD101151
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Spastic Gait; Foot Drop

Outcome Measures

Primary Outcomes (2)

• Volitional Ankle Control-Tapping Task Performance

  The participant will be seated with the foot positioned on a pressure sensitive switch embedded in a platform. Participants will be asked to voluntarily contract and relax the muscles that lift the front of the foot (while the heel stays in place on the platform) as quickly as possible for 10s for 4 trials with a 60s rest in between.

  Through study completion at 2 weeks

• Ankle Spasticity-Ankle Clonus

  This test measures the amount of spasticity in the ankle. Motion sensors to record the ankle joint angles will be used. For this test participants will sit upright. The leg will be raised and released allowing the front of the foot to land on the edge of a platform. The angle of the ankle and movement of the foot will be recorded as it drops and catches on the platform.

  Through study completion at 2 weeks

Secondary Outcomes (6)

• Corticospinal tract excitability-Motor Evoked Potentials

  Through study completion at 2 weeks

• Low frequency depression

  Through study completion at 2 weeks

• Spinal Cord Assessment Tool for Spastic Reflexes

  Through study completion at 2 weeks

• Ankle Isometric Strength Test

  Through study completion at 2 weeks

• Walking speed and walking pattern

  Through study completion at 2 weeks

Study Arms (2)

Corticospinal Tract Excitability

ACTIVE COMPARATOR

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.

Other: Whole Body Vibration (WBV); Other: Electrical Stimulation

Spinal Reflex Circuit Excitability

ACTIVE COMPARATOR

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.

Other: Whole Body Vibration (WBV); Other: Electrical Stimulation

Interventions

Whole Body Vibration (WBV) OTHER

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

Corticospinal Tract Excitability; Spinal Reflex Circuit Excitability

Electrical Stimulation 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.

Corticospinal Tract Excitability; Spinal Reflex Circuit Excitability

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Gait Disorders, Neurologic; Peroneal Neuropathies

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Edelle Field-Fote, PT, PhD

  Director of Spinal Cord Injury Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Spinal Injury Research & The Hulse Spinal Injury Laboratory

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 23, 2020
• Study Start: July 6, 2021
• Primary Completion: July 9, 2021
• Study Completion: July 9, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)