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ENROLLING BY INVITATION
NCT07683780
NA

Spinal Stimulation + FES-Assisted Cough Training in SCI

Sponsor: Milap Sandhu

View on ClinicalTrials.gov

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.

Official title: Combined Transcutaneous Spinal Stimulation + FES-Assisted Cough Training in Acute SCI

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-06-15

Completion Date

2030-01

Last Updated

2026-07-06

Healthy Volunteers

Yes

Interventions

OTHER

tSCS combined with FES-Cough

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.

OTHER

Sham tSCS + FES assisted cough

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.

Locations (1)

Shirley Ryan AbilityLab

Chicago, Illinois, United States