NCT07683780

Brief Summary

The overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) is an effective intervention to improve cough strength and coordination in individuals with acute/subacute SCI.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
41mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jan 2030

First Submitted

Initial submission to the registry

June 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

June 12, 2026

Last Update Submit

July 1, 2026

Conditions

Spinal Cord Injuries

Keywords

Spinal StimulationCoughFunctional Electrical Stimulation

Outcome Measures

Primary Outcomes (2)

  • Peak Cough Flow

    Assesses functional cough strength via a digital peak flow by asking the participant to cough three times into the device. The maximum number will be recorded.

    From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks

  • Cough Partial Expiratory Flow Volume

    Assesses the effectiveness of a cough by plotting airflow during the cough against lung volume, and allowing all phases of cough to be visualized and calculate spirometric measurements. The participant will be fit with a facemask that will go over their nose and mouth, and then be asked to perform a series of single coughs and sequential coughs.

    From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks

Secondary Outcomes (4)

  • Maximum inspiratory pressure

    From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks

  • Changes in electromyography (EMG) of respiratory muscles

    From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks

  • Maximum expiratory pressure

    From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks

  • Forced expiratory volume

    From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks

Study Arms (2)

Sham tSCS + FES-Assisted Cough

SHAM COMPARATOR

In this group, the tSCS spinal stimulation will be sham, providing no additional electrical input, while the FES assisted cough intervention will remain

Other: Sham tSCS + FES assisted cough

tSCS + FES-Assisted Cough

ACTIVE COMPARATOR

This group will receive the combination of tSCS spinal stimulation and FES assisted cough simultaneously

Other: tSCS combined with FES-Cough

Interventions

tSCS combined with FES-CoughOTHER

A clinician will don the electrodes on the participant for 20, 30 minute sessions 2 to 4 times per week for 4 to 6 weeks. tSCS will utilize multi-site stimulation at C3-C4 and T9-10, with simulation intensity being set for each electrode which produces a visible muscle twitch. FES will be set up by placing electode pads in the posterolateral positon on the trunk. Baseline stimulation parameters are 50Hz Frequency, 250-400μs pulse duration, altering monophasic waveform, amplitude dependent on participant response.

tSCS + FES-Assisted Cough
Sham tSCS + FES assisted coughOTHER

A clinician will don the electrodes on the participant for 20, 30 minute sessions 2 to 4 times per week for 4 to 6 weeks. tSCS will utilize multi-site stimulation at C3-C4 and T9-10, with simulation intensity being set for each electrode which produces a visible muscle twitch. The sham group will have intensity will be ramped up to sensation for 1 minute then ramped down and turned off FES will be set up by placing electode pads in the posterolateral positon on the trunk. Baseline stimulation parameters are 50Hz Frequency, 250-400μs pulse duration, altering monophasic waveform, amplitude dependent on participant response.

Sham tSCS + FES-Assisted Cough

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently admitted for inpatient rehabilitation at Shirley Ryan AbilityLab
  • History of traumatic spinal cord injury with Neurologic Level of Injury (NLI) C1-T1, and AIS A-C on admission exam
  • Between 14-60 days from date of injury at time of enrollment
  • Baseline PCF below 270 L/min
  • Anatomical airway or tolerating occlusion of tracheostomy with either a one-way speaking valve or a cap for at least 60 minutes
  • Medically cleared by the participants primary inpatient physiatry attending physician

You may not qualify if:

  • Individuals with pre-morbid chronic pulmonary conditions, day-time ventilator dependence, uncontrolled autonomic dysreflexia, moderate to severe traumatic brain injury, developmental delay, diagnosis of active cancer, or secondary progressive neurologic disorder
  • Individuals with contraindications to the interventions of interest:
  • TSCS and Abdominal FES: pacemaker, compromised skin integrity under site of stimulation, implanted defibrillators, deep brain stimulator(s), uncontrolled epilepsy or seizures, pregnancy, recent myocardial infarct, diaphragmatic pacer
  • TSCS: Severe osteoporosis
  • Abdominal FES: unhealed rib fracture, sternal precautions, recent pneumothorax, spine bracing impacting ability to place stimulation pads.
  • Individuals who are currently enrolled in another interventional research study are excluded from participating to eliminate potential influence of additional experimental interventions on study outcomes and to maintain standardization of study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesCough

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Milap Sandhu, PhD, PT

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2026

First Posted

July 6, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

January 1, 2030

Last Updated

July 6, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Upon request, de-identified data may be shared by the principal investigator

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Until 3 years following conclusion of study procedures
Access Criteria
Principal investigator will retain this access and distribute upon request

Locations

US(1)