Neurostimulation for Respiratory Function After Spinal Cord Injury

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT05756894
Status
Recruiting
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Conditions

  • Cervical Spinal Cord Injury
  • Respiratory Function Impaired
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Neurostimulation — DEVICE
    Paired stimulation will be given to the spinal cord and to peripheral nerves so that the signals are received at the spinal cord at a specific interval.
  • Repiratory training — OTHER
    Respiratory exercises will be completed immediately after completing neurostimulation. Respiratory exercises will involve inspiratory muscle training performing four sets of 6-10 breaths per day with two minutes of rest.

Study Details

The purpose of this research study is to learn more about the connections between the brain, nerves, and diaphragm after experiencing a cervical spinal cord injury (SCI).The main question it aims to answer is: Changes in respiratory function and recovery using stimulation and respiratory exercise training in spinal cord-injured individuals. Participants will complete a maximum of 55 study visits. They will be asked to complete about 40 treatment sessions which include multiple stimulation sessions over the scalp and neck, followed by about 60 minutes of respiratory training. Assessment sessions will be completed prior at baseline, after 20 sessions and after 40 sessions of study treatment.

Key Dates

Start date
Feb 28, 2023
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neurostimulation for respiratory function after spinal cord injury
    Efficacy of STDP on respiratory function.

Primary Outcome Measure

Change in Motor evoked potentials (MEPs) [ Time Frame: MEPs measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan Ability LabChicagoIllinois60611
Sri Ramya Vemulakonda, MBBS
[email protected]
312-238-2993
Monica Perez, PhD (PRINCIPAL_INVESTIGATOR)

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Shirley Ryan Ability Lab· Chicago, IL

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