Enhancing Corticospinal Activation for Improved Walking Function

NCT03237234 | Completed Results DMC FDA Device

• 1 other identifier: SCIMS1-703
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve extensive rehabilitation training and access to facilities, qualified staff, and advanced technology that make practicing walking at home difficult. For this reason, developing training approaches that could be easily performed in the home would be of great value. In addition, non-invasive brain stimulation has the potential to increase the effectiveness of communication between the brain and spinal cord. Combining motor skill training with brain stimulation may further enhance the restoration of function in persons with SCI. Based on these findings, the primary aim of this proof-of-concept study is to inform future intervention development. To meet this aim, we will determine if moderate-intensity, motor skill training can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive brain stimulation will result in greater improvements in function compared to training alone.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 10 Meter Walk Test (Walk Speed)

  Walking speed was the primary outcome measure for walking function, as speed has been the standard measure used in the literature and allowed us to assess outcomes relative to other published studies. Walking speed was determined using the 10-Meter Walk Test. Participants completed 3 walk trials at each time point, separated by 2 minutes of seated rest. The average walking speed of 3 walks was calculated and used in the analyses. Data reported were obtained at baseline at Day 1 (D1) and at follow-up on Day 5 (D5), 24-hours post-intervention.

  D1, D5

Secondary Outcomes (11)

• Spatiotemporal Gait Characteristic (Cadence)

  D1, D5

• Spatiotemporal Gait Characteristic (Stride Length - Weaker Limb)

  D1, D5

• Spatiotemporal Gait Characteristic (Stride Length - Stronger Limb)

  D1, D5

• Spatiotemporal Gait Characteristic (Step Length Symmetry - Symmetry Index)

  D1, D5

• Maximal Isometric Dorsiflexor Strength

  D1, D5

Study Arms (2)

Motor Training + Sham tDCS

SHAM COMPARATOR

Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (tDCS).

Other: Motor Skill Training

Motor Training + tDCS

EXPERIMENTAL

Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (tDCS) delivered at 2mA to the motor cortex.

Other: Motor Skill Training; Device: Transcranial direct current stimulation (tDCS)

Interventions

Motor Skill Training OTHER

Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MT, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.

Motor Training + Sham tDCS; Motor Training + tDCS

Transcranial direct current stimulation (tDCS) DEVICE

The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MT activities. As reported previously, participants in the MT-only group will receive sham tDCS to maintain analogous study procedures.

Motor Training + tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a spinal cord injury (neurological level C3-T10);
• Chronic SCI (12 months or greater);
• Neurological impairment classification C or D;
• Able to stand for at least 5 minutes (with or without an assistive device);
• Able to move each leg independently for at least 3 steps;
• Able to rise from sit to stand with moderate assistance from one person;
• Ability and willingness to consent and authorize use of personal health information.

You may not qualify if:

• Progressive spinal lesions including degenerative, or progressive vascular disorders of the spine and/or spinal cord;
• Injuries below the neurological spinal level of T10;
• History of cardiovascular irregularities;
• Altered cognitive status;
• Presence of orthopedic conditions that would adversely affect participation in exercise;
• Implanted metallic objects in the head;
• History of seizures;
• Inability and unwillingness to consent and authorize use of personal health information.

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Shepherd Center, Inc.

Atlanta, Georgia, 30309, United States

Location

Related Publications (2)

• Evans NH, Suri C, Field-Fote EC. Walking and Balance Outcomes Are Improved Following Brief Intensive Locomotor Skill Training but Are Not Augmented by Transcranial Direct Current Stimulation in Persons With Chronic Spinal Cord Injury. Front Hum Neurosci. 2022 May 11;16:849297. doi: 10.3389/fnhum.2022.849297. eCollection 2022.

  PMID: 35634208 DERIVED

• Evans NH, Field-Fote EC. A Pilot Study of Intensive Locomotor-Related Skill Training and Transcranial Direct Current Stimulation in Chronic Spinal Cord Injury. J Neurol Phys Ther. 2022 Oct 1;46(4):281-292. doi: 10.1097/NPT.0000000000000403. Epub 2022 May 11.

  PMID: 35544283 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Edelle C. Field-Fote
• Organization: Shepherd Center

edee.field-fote@shepherd.org

404-603-4274

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Spinal Cord Injury Research

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: August 2, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: July 1, 2021
• Last Updated: January 12, 2022
• Results First Posted: October 14, 2021

Record last verified: 2021-12

Locations

US (1)