Neural Facilitation of Movements in People With SCI

NCT05354206 | Terminated Results

• 1 other identifier: 202111151
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord injury leads to long-lasting paralysis and impairment. Re-enabling movement of paralyzed areas is challenging and more information is needed about neurological recovery. The purpose of this study is to understand the contribution of individual neural tracts to movements facilitated by transcutaneous spinal cord stimulation (SCS).

Conditions

Spinal Cord Injuries

Keywords

spinal cord injury; spinal cord stimulation; rehabilitation; neuromodulation

Outcome Measures

Primary Outcomes (2)

• Changes in Corticospinal Tract Excitability After Training

  This primary outcome is a measure of changes in corticospinal tract excitability as quantified by changes in the amplitude size of motor evoked potentials. Data for this arm were not collected due to early study termination.

  30 minutes before and 30 minutes into intervention

• Reticulospinal Tract Excitability During Different Types of Movements

  This primary outcome measures changes in reticulospinal tract excitability (RST) during training as quantified by changes in reaction time after a startling auditory stimulus. RST contrubution was evaluated for dorsiflexion, plantarflexion, hip flexion movements during precision and range of motion control tasks under three conditions: with transcutaneous spinal cord stimulation or without stimulation. All conditions/evaluations were performed in the same session. 30 repetitions were performed per condition during a single session and averaged for each participant. RST is a ratio calculated by = (visual - startle)/(visual - auditory), where: visual represents the reaction time to a visual cue, auditory represents the reaction time to an auditory cue, startle represents the reaction time to a startling cue. A RST ratio value greater than 1 would indicate a significant contribution of the reticulospinal tract for a given task. A value equal or lower than 1 would suggest

  During intervention, *1 Day*.

Study Arms (2)

Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements

EXPERIMENTAL

This arm will receive the transcranial magnetic stimulation to evaluate the excitability of the corticospinal tract first then the arm will receive the loud auditory stimuli to evaluate the excitability of the reticulospinal track second.

Other: Electrophysiology assessment - corticospinal tract; Other: Training with some stimulation

Reaction time evaluation during non-invasive spinal cord stimulation and leg movements

EXPERIMENTAL

This arm will receive the loud auditory stimuli to evaluate the excitability of the reticulospinal tract first then the arm will receive the transcranial magnetic stimulation to excite the corticospinal tract second

Other: Electrophysiology assessment - reticulospinal tract; Other: Training with some stimulation

Interventions

Electrophysiology assessment - corticospinal tract OTHER

Kinematics and cortical spinal motor excitability

Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements

Electrophysiology assessment - reticulospinal tract OTHER

Kinematics and reticular spinal motor excitability

Reaction time evaluation during non-invasive spinal cord stimulation and leg movements

Training with some stimulation OTHER

Motor task combined with real or sham stimulation

Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements; Reaction time evaluation during non-invasive spinal cord stimulation and leg movements

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Age between 16-65
• Healthy individuals with no major conditions of any organ system

You may not qualify if:

• Healthy volunteers
• Not willing or able to provide consent
• Any acute or chronic pain condition
• Any acute or chronic disease of a major organ system
• Use of analgesics within 24 hours prior to study appointment
• Use of caffeine with 3 hours of study appointment
• History of epilepsy
• Implanted metal
• Active medical problems
• Participants with spinal cord injury (SCI)
• Age between 16-65
• Traumatic SCI C4-T9 level, complete (ASIA A) or incomplete (ASIA B, C or D)
• at least 1 year post injury
• Stable medical condition
• difficulty independently performing leg movements in routine activities

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63105, 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

Limitations and Caveats

The study was terminated early due to a transition to a new grant with overlapping effort. Therefore, while some data was collected for Aim 2, no data was collected for Aim 1. The statistical analysis was not completed during the duration of the study.

Results Point of Contact

• Title: Dr. Ismael Seáñez
• Organization: Washington University in St. Louis

ismaelseanez@wustl.edu

3149357665

Study Officials

• Ismael Seanez, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Biomedical Engineering and Neurosurgery

Model Details: After baseline evaluations of the effect of transcutaneous SCS on single pulse responses, motor function, and a familiarization phase on a body-machine interface, participants will be randomly assigned to one of two arms in the study. Arm 1: Participants will receive interventions A and B and transcranial magnetic stimulation is used to evaluate the excitability of the corticospinal tract. Arm 2: Participants will receive interventions A and B and a loud auditory stimuli is used to evaluate the excitability of the reticulospinal tract. Arms 1 and 2 will run in parallel. Participants will perform interventions A and B in a randomized cross-over design. In both interventions A and B, participants will use their legs to control a computer cursor as transcutaneous spinal cord stimulation is delivered. Intervention A, participants perform a range-of-motion task, while in intervention B, participants perform a precision-control task.

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: June 23, 2022
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: November 22, 2024
• Results First Posted: November 22, 2024

Record last verified: 2024-10

Locations

US (1)