Spinal Stimulation + FES-Assisted Cough Training in SCI

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Milap Sandhu
Study ID
NCT07683780
Status
Enrolling By Invitation

Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • tSCS combined with FES-Cough — OTHER
    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.
  • Sham tSCS + FES assisted cough — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Sham tSCS + FES-Assisted Cough
    In this group, the tSCS spinal stimulation will be sham, providing no additional electrical input, while the FES assisted cough intervention will remain
  • Active Comparator: tSCS + FES-Assisted Cough
    This group will receive the combination of tSCS spinal stimulation and FES assisted cough simultaneously

Primary Outcome Measure

Peak Cough Flow [ Time Frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60611-

Find similar trials in Chicago, IL

By research site
Shirley Ryan AbilityLab· Chicago, IL

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