Combining tsDCS and Exoskeleton Gait Training on Spinal Excitability in SCI

NCT ID: NCT02862080

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-13
• Study Completion Date: 2017-11-17

Brief Summary

The purpose of the study is to determine whether transcutaneous spinal direct current stimulation (tsDCS) is safe for individuals with spinal cord injury (SCI). tsDCS is an electrical current applied to the skin. The plan is to also study the potential neurophysiological changes (changes in speed and excitability of the nerves) and functional improvements in gait (for example, gait quality, speed and walking distance) for individuals with SCI after combined application of tsDCS and exoskeleton assisted gait training.

Detailed Description

Subjects will participate in two baseline visits, 4 days apart. Each baseline visit will last 1 hour and will include assessment of soleus H-Reflex and 10 meter walk test on arrival and 40 minutes after the initial assessment. Subjects will be asked to minimize their activity between assessments by either sitting in a chair or lying on a mat.

Each training visit will involve either an exoskeleton intervention or a combined exoskeleton and tsDCS intervention. Each training visit will include assessment of soleus H-Reflex and 10 meter walk test before and after the exoskeleton intervention or before and after the combined exoskeleton and tsDCS intervention.

Conditions

Spinal Cord Injury

Study Design

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

Study Groups

no intervention; then no intervention; then cathode tsDCS + Ekso; then Ekso; then cathode tsDCS+Ekso

Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.

Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.

Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.

Group Type: EXPERIMENTAL

cathode tsDCS

Intervention Type: DEVICE

Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.

Ekso

Intervention Type: DEVICE

Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.

no intervention; then no intervention; then Ekso; then cathode tsDCS + Ekso; then Ekso

Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.

Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.

Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.

Group Type: EXPERIMENTAL

cathode tsDCS

Intervention Type: DEVICE

Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.

Ekso

Intervention Type: DEVICE

Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.

no intervention; then no intervention; then anode tsDCS + Ekso; then Ekso; then anode tsDCS + Ekso

Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.

Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.

Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.

Group Type: EXPERIMENTAL

Ekso

Intervention Type: DEVICE

Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.

anode tsDCS

Intervention Type: DEVICE

Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.

no intervention; then no intervention; then Ekso; then anode tsDCS + Ekso; then Ekso

Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.

Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.

Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.

Group Type: EXPERIMENTAL

Ekso

Intervention Type: DEVICE

Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.

anode tsDCS

Intervention Type: DEVICE

Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.

Interventions

cathode tsDCS

Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.

Intervention Type: DEVICE

Ekso

Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.

Intervention Type: DEVICE

anode tsDCS

Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or non-pregnant female
• ≥18 years of age
• Able to achieve adequate fit within exoskeleton
• Diagnosis of spinal cord injury (SCI), T10 level and above (T11 and 12 may participate if no clinical signs of lower motor neuron lesion present)
• Minimum of 6 months post injury
• Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
• Weight <220 pounds
• Intact skin on all surfaces in contact with device and load bearing surfaces
• Ability to perform informed consent

Exclusion Criteria

• Pregnancy
• Spinal instability
• Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
• Presence of peripheral neuropathy or any pathology that could influence reflex excitability
• Diagnosis of other neurological injury other than SCI such as stroke/cerebrovascular accident (CVA), multiple sclerosis (MS), acquired brain injury (ABI), cerebral palsy (CP)
• Uncontrolled spasticity (≥3 on Modified Ashworth Scale)
• Colostomy
• Decreased range of motion or contractures in legs (>10° at hips, knees or ankles)
• Uncontrolled autonomic dysreflexia
• Unresolved deep vein thrombosis
• Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
• Severe comorbidities: active infections, heart, lung, or circulatory conditions
• Pressure sores, impaired skin integrity
• Use of mechanical ventilation for respiratory support
• Presence of any of the following contraindications to electrical stimulation: cardiac pacemaker, deep brain stimulator, or evidence of cancerous (malignant) tissue
• Presence of metal in thoracic spine or region of electrode placement

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

Sponsors

TIRR Memorial Hermann

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Marcie Kern

Research Physical Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcie Kern, PT, MSPT

Role: PRINCIPAL_INVESTIGATOR

TIRR Memorial Hermann

Locations

NeuroRecovery Research Center at TIRR Memorial Hermann

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-16-0329

Identifier Type: -

Identifier Source: org_study_id