Non-Invasive Spinal Cord Stimulation After Injury

NCT03998527 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 17.1279
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess the function of the lungs and the muscles are used to breathe after individuals receive respiratory training, spinal cord stimulation, a combination of respiratory training and stimulation, a combination of arm training and stimulation, or a combination of trunk training and stimulation. The respiratory, arm, and trunk training combined with the spinal stimulation interventions are being used to activate the spinal cord below the level of injury. Investigators will be looking for changes in the function of the lungs and trunk muscles before, during, and after these task-specific and non-task-specific interventions for breathing to determine which one has the greatest effect. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that have impaired lung, arm, and trunk function.

Conditions

Spinal Cord Injuries

Keywords

Respiration; Motor control

Outcome Measures

Primary Outcomes (3)

• Non-invasive respiratory electromyography

  Respiratory muscle activity evaluated using vector analysis outcome measure.

  Through study completion, an average of 1 year.

• Spirometry

  Respiratory activity evaluated using airflow outcome measure.

  Through study completion, an average of 1 year.

• Maximum airway pressure

  Respiratory activity evaluated using airway pressure measurement.

  Through study completion, an average of 1 year.

Secondary Outcomes (7)

• Functional Neurophysiological Assessment (FNPA)

  Through study completion, an average of 1 year.

• Multisegmental Motor Response (MMR)

  Through study completion, an average of 1 year.

• Transcranial Magnetic Stimulation (TMS)

  Through study completion, an average of 1 year.

• Aerobic Endurance Test (VO2Peak)

  Through study completion, an average of 1 year.

• Spinal Cord Independence Measure (SCIM)

  Through study completion, an average of 1 year.

Study Arms (2)

Non-Disabled (ND) and Spinal Cord Injured (SCI) controls

EXPERIMENTAL

The ND Control group (n=6) and SCI Control group (n=6) will be used to assess related values as acute effects of transcutaneous electrical spinal cord stimulation (TcESCS) itself and will not receive any training intervention. The ND group will receive baseline assessments, then up to 12 (4-Respiratory function, 4-Arm function, and 4-Trunk function) TcESCS mapping experiments, followed by repeating the assessments in the presence of TcESCS. The investigators will decide which stimulation type should be used for the post-mapping assessments.

Device: Transcutaneous Electrical Spinal Cord Stimulation (TcESCS)

Spinal Cord Injured (SCI) intervention groups

EXPERIMENTAL

The respiratory training (RT) group (n=6) will receive the respiratory training intervention only); the transcutaneous electrical spinal cord stimulation (TcESCS) group (n=6) will receive transcutaneous spinal cord stimulation only; TcESCS + RT group (n=6) will receive TcESCS combined with RT; TcESCS + Arm Training (AT) group (n=6) will receive TcESCS combined with AT; and TcESCS + Trunk Training (TT) group (n=6) will receive TcESCS combined with TT.

Device: Transcutaneous Electrical Spinal Cord Stimulation (TcESCS)

Interventions

Transcutaneous Electrical Spinal Cord Stimulation (TcESCS) DEVICE

TcESCS is a non-invasive DC battery powered device. Investigators and/or research team members will continually assess the appropriate stimulation parameters including configurations, current, voltage and frequency delivered by up to five active electrodes applied on skin of the back from cervical to lumbar levels. Stimulation parameters used during experimental assessments and interventions will be closely monitored by the research team. Every research participant will be slowly acclimated to stimulation. Blood pressure, heart rate, respiratory rate, and electromyography will be closely monitored while we are determining the correct stimulation parameters in the lab. During the stimulation training sessions, we will monitor blood pressure regularly throughout the session.

Also known as: Non-invasive spinal cord stimulation

Non-Disabled (ND) and Spinal Cord Injured (SCI) controls; Spinal Cord Injured (SCI) intervention groups

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age at the time of enrollment;
• Stable medical condition;
• Non-progressive SCI T5 or above;
• Sustained SCI at least 12 months prior to enrollment;
• At least a 15% deficit in pulmonary function outcomes (FVC or FEV1) as was detected by screening spirometry

You may not qualify if:

• Untreated musculoskeletal dysfunction;
• Unhealed fracture;
• Untreated contracture or pressure sore;
• Ventilator dependence;
• Untreated depression, psychiatric disorder, or ongoing drug abuse;
• Major pulmonary or cardiovascular disease;
• Major esophageal or gastrointestinal disease;
• Endocrine disorder, malignancy, marked obesity, deep vein thrombosis, or HIV/AIDS related illness;
• Secondary causes of orthostatic hypotension (anemia, hypervolemia, endocrine, or neurological);
• Pregnancy by self-report.
• All Non-Disabled research participants, irrespective of gender, will be selected based on the following:
• At least 21 years of age at the time of enrollment.
• FVC and FEV1 values 80% of predicted or above indicating healthy pulmonary function by screening spirometry.
• History of respiratory disease by self-report,
• History of cardiovascular disease by self-report.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Frazier Rehabilitation and Neuroscience Institute

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.

  PMID: 26205686 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Ovechkin, MD, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Professor

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 26, 2019
• Study Start: May 17, 2018
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)