Lower Limb Function After Spinal Cord Injury

NCT02635893 | Completed Phase 4

• 1 other identifier: 20150605
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, experimental study that examines the physiology of central nervous system pathways contributing to the control of bilateral movements in individuals with spinal cord injuries and promotes the recovery of lower-limb motor function through the use of stimulation and locomotor training.

Conditions

Spinal Cord Injury

Keywords

SCI

Outcome Measures

Primary Outcomes (1)

• Changes in motor evoked potential size

  30 minutes before and 30 minutes after intervention

Study Arms (3)

D-Cycloserine/Placebo + Stimulation

ACTIVE COMPARATOR

Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation.

Drug: D-Cycloserine; Drug: Placebo; Other: Stimulation

Training+Med/Placebo+Stimulation

ACTIVE COMPARATOR

Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation followed by training.

Drug: D-Cycloserine; Drug: Placebo; Other: Training; Other: Stimulation

Training+Med+Stimulation/Placebo Stim

ACTIVE COMPARATOR

Participant will be given a single dose of 100 mg of D-Cycloserine or placebo before receiving stimulation or placebo stimulation followed by training.

Drug: D-Cycloserine; Other: Training; Other: Stimulation; Other: Placebo Stimulation

Interventions

D-Cycloserine DRUG

100 mg of Seromycin by mouth will be administered

Also known as: Seromycin

D-Cycloserine/Placebo + Stimulation; Training+Med+Stimulation/Placebo Stim; Training+Med/Placebo+Stimulation

Placebo DRUG

placebo pill will be administered instead of medication by mouth

Also known as: Placebo Drug

D-Cycloserine/Placebo + Stimulation; Training+Med/Placebo+Stimulation

Training OTHER

walking around a designated track at different speeds both forward and backward

Training+Med+Stimulation/Placebo Stim; Training+Med/Placebo+Stimulation

Stimulation OTHER

magnetic stimulation and electrical stimulation may be applied

D-Cycloserine/Placebo + Stimulation; Training+Med+Stimulation/Placebo Stim; Training+Med/Placebo+Stimulation

Placebo Stimulation OTHER

this is a fake stimulation that is administered but will be unknow to the subject.

Training+Med+Stimulation/Placebo Stim

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females between ages 18-85 years of age
• SCI ( ≥1 month of injury)
• ASIA A, B,C and D
• SCI above L5
• Able to perform a visible contraction with dorsiflexor and hip flexor muscles (allowing testing of largely impaired patients)
• Able to ambulate a few steps with or without an assistive device
• Male and females between ages 18-85 years of age
• Able to walk and complete lower-limb tests with both legs

You may not qualify if:

• Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease,
• Any debilitating disease prior to the SCI that caused exercise intolerance
• Premorbid, ongoing major depression or psychosis, altered cognitive status
• History of head injury or stroke,
• Metal plate in skull
• History of seizures
• Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.
• Pregnant females, and
• Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk.
• Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease,
• Any debilitating disease that causes exercise intolerance
• Premorbid, ongoing major depression or psychosis, altered cognitive status
• History of head injury or stroke,
• Metal plate in skull
• History of seizures

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

The Shirley Ryan Ability Lab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Monica A Perez, PT, Phd

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Arms + Hands Lab

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 21, 2015
• Study Start: June 21, 2019
• Primary Completion: March 9, 2021
• Study Completion: April 11, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)