Combining tsDCS and Exoskeleton Gait Training on Spinal Excitability in SCI

NCT02862080 | Completed Results FDA Device

• 1 other identifier: HSC-MS-16-0329
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (4)

• Change in Spinal Cord Excitability as Measured by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session

  This visit includes assessment of soleus H-Reflex on arrival and 40 minutes after the initial assessment--change between these two readings is reported. Subjects will be asked to minimize their activity between the two assessments by either sitting in a chair or lying on a mat. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg.

  beginning and end of first no-intervention visit (7 days before any intervention)

• Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session

  This visit includes assessment of soleus H-Reflex on arrival and 40 minutes after the initial assessment--change between these two readings is reported. Subjects will be asked to minimize their activity between the two assessments by either sitting in a chair or lying on a mat. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg.

  beginning and end of second no-intervention visit (3 days before any intervention)

• Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session

  Soleus H-Reflex is assessed on arrival and then after the intervention is applied--change between these two readings is reported. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg.

  before and after intervention on day 1

• Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session

  Soleus H-Reflex is assessed on arrival and then after the intervention is applied--change between these two readings is reported. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg.

  before and after intervention on day 5

Secondary Outcomes (7)

• Gait Speed as Assessed by 10 Meter Walk Test

  first no-intervention visit (7 days before any intervention)

• Gait Speed as Assessed by 10 Meter Walk Test

  second no-intervention visit (3 days before any intervention)

• Gait Speed as Assessed by 10 Meter Walk Test

  Day 1 of intervention

• Gait Speed as Assessed by 10 Meter Walk Test

  Day 2 of intervention

• Gait Speed as Assessed by 10 Meter Walk Test

  Day 3 of intervention

Study Arms (4)

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

EXPERIMENTAL

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.

Device: cathode tsDCS; Device: Ekso

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

EXPERIMENTAL

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.

Device: cathode tsDCS; Device: Ekso

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

EXPERIMENTAL

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.

Device: Ekso; Device: anode tsDCS

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

EXPERIMENTAL

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.

Device: Ekso; Device: anode tsDCS

Interventions

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

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

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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• TIRR Memorial Hermann: collaborator

Study Sites (1)

NeuroRecovery Research Center at TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Marcie Kern, PT, MSPT
• Organization: The University of Texas Health Science Center at Houston

neurorecoveryresearch@memorialhermann.org

713-799-6995

Study Officials

• Marcie Kern, PT, MSPT

  TIRR Memorial Hermann

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physical Therapist

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: August 10, 2016
• Study Start: February 13, 2017
• Primary Completion: November 17, 2017
• Study Completion: November 17, 2017
• Last Updated: January 20, 2021
• Results First Posted: January 20, 2021

Record last verified: 2021-01

Locations

US (1)