Spinal Cord Stimulation to Augment Activity Based Therapy

NCT ID: NCT03240601

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-09-11

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.

Detailed Description

Involuntary muscle activity, often referred to as spasticity, is a common problem following spinal cord injury. Spasticity can be evoked by stimuli or occur spontaneously, and it can manifest as spasms, clonus, or the stiffness associated with hypertonia. While medications are typically used to treat the general symptoms of spasticity, they often have additional side effects, like muscle weakness, that can impede rehabilitation. Physical therapeutics offer an alternative to these drug treatments, but the most effective therapeutic strategy for managing spasticity has not yet been identified. A combination of physical therapeutics may provide the best strategy for managing spasticity while also improving general motor control for functional movements.

Walking ability can be improved through locomotor training, which has also been shown to reduce spasticity. When locomotor training is combined with electrical stimulation, the benefits of training may be increased. To investigate the potential benefits of this combinatorial treatment strategy, investigators will use a kind of electrical stimulation called transcutaneous spinal cord stimulation ("TSS") to stimulate spinal cord nerves during locomotor training.

In order to facilitate the translation of study findings into clinical practice, this study uses a pragmatic design, meaning that the study will involve the use of real world clinical settings and practices. Participants will undergo their standard physical therapist directed locomotor training program while receiving transcutaneous spinal cord stimulation (TSS) as an additional treatment. The effects of locomotor training alone will be compared to the combination of locomotor training with TSS, specifically comparing the effects of these treatments on spasticity and walking function.

Investigators expect that the combination of TSS with locomotor training will provide 1) a greater reduction in spasticity and 2) a greater improvement of walking function compared to locomotor training alone.

The findings from this study have the potential to rapidly facilitate the translation of a novel combination treatment for the management of spasticity and improvement of walking function into real world clinical practice.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Subthreshold

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.

Group Type: SHAM_COMPARATOR

Transcutaneous spinal stimulation

Intervention Type: 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.

Active

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.

Group Type: EXPERIMENTAL

Transcutaneous spinal stimulation

Intervention Type: 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.

Interventions

Transcutaneous spinal stimulation

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.

Intervention Type: DEVICE

Other Intervention Names

TSS

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation Wings For Life

OTHER

Sponsor Role: collaborator

Shepherd Center, Atlanta GA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edelle C Field-Fote, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Shepherd Center, Inc

Locations

Shepherd Center, Inc.

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

696

Identifier Type: -

Identifier Source: org_study_id