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Neurostimulation for Respiratory Function After Spinal Cord Injury

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurostimulation
Repiratory training
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Neural plasticity, Spinal cord injury, Diaphragm, Respiratory training, Spike-timing-dependent plasticity, Neurostimulation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and females between ages 18-85 years SCI at least 6 months post-injury Spinal Cord injury at C1-C5 Demonstrate respiratory deficit following spinal cord injury as following: (1) Individuals using mechanical ventilation, and (2) individuals with pulmonary function testing (PFT) deficits corresponding to having a vital capacity (VC) < 80% (predicted) Must have a family member or caregiver who is trained and willing to operate the mechanical ventilator during study visits. Exclusion Criteria: Any illness or condition that based on the research team's assessment, will compromise with the participant's ability to comply with the protocol, patient safety, or the validity of the data collected during this study. Any debilitating disease prior to the SCI that caused exercise intolerance. Individuals entirely dependent on the support of a diaphragmatic pacer (24 hours per day). Premorbid, ongoing major depression or psychosis, altered cognitive status. History of head injury or stroke Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication History of seizures or epilepsy Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold Pregnant females If a woman of childbearing age is unsure of the pregnancy, and does not want to take the pregnancy test Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk Metal plate in skull Individuals with scalp shrapnel, cochlear implants, or aneurysm clips Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs

Sites / Locations

  • Shirley Ryan Ability LabRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurostimulation for respiratory function after spinal cord injury

Arm Description

Efficacy of STDP on respiratory function.

Outcomes

Primary Outcome Measures

Change in Motor evoked potentials (MEPs)
Transcranial magnetic stimuli (TMS) will be delivered to the optimal scalp position for activation of the diaphragm muscle. The optimal scalp position will be determined by moving the coil in small steps along the diaphragm representation of the primary motor cortex to find the region where the largest MEP can be evoked with the minimum intensity in the targeted muscles.
Change in Maximum Voluntary Contractions (MVCs)
Individuals will perform a maximum voluntary contraction (MVC) of diaphragm muscle through surface electrodes secured to the skin over the chest and belly region.

Secondary Outcome Measures

Change in Cervicomedullary electric potentials (CMEPs)
Transcranial magnetic stimuli will be delivered to the optimal position of the cervical spine. A small device on the surface of the skin behind the ear will deliver pulses of electricity over the back of the neck.
Change in Pulmonary function tests
Spirometry will be tested in upright and supine position to measure negative inspiratory force (NIF), vital capacity (VC), forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and their ration (FEV1/FVC)
Change in the Diaphragm ultrasound imaging
Ultrasound imaging will be acquired for optimal visualization of each hemidiaphragm. The diaphragm will be examined during quiet breathing and during maximal inspiration. MVCs measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures.

Full Information

First Posted
February 23, 2023
Last Updated
April 27, 2023
Sponsor
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT05756894
Brief Title
Neurostimulation for Respiratory Function After Spinal Cord Injury
Official Title
Pilot Study: Spike-timing-dependent Plasticity for Respiratory Function After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The purpose of this study is to test a strategy to potentiate functional recovery of respiratory function in individuals with spinal cord injury (SCI). Respiratory function is often impaired in individuals with high cervical spinal cord injury (SCI, C1-C5) leading to reduced quality of life and mortality. Currently, research has shown Spike-timing-dependent plasticity (STDP) targeting cortico-motoneuronal connections effectively promote recovery in upper and lower limbs, including functions such as grasping and locomotion. The overall goal of our proposal is to develop a non-invasive protocol using STDP that can be used to strengthen synaptic plasticity and voluntary motor output in the diaphragm muscle in humans with high cervical SCI. To assess the effect of STDP on respiratory function in humans with high cervical SCI, we propose a pilot study of efficacy trial with the specific aim below: The overall objective of this project is to investigate the efficacy of spike-timing-dependent plasticity (STDP) on respiratory function in humans with high cervical SCI. Specific Aim: Examine the effect of STDP in respiratory function in humans with chronic high cervical SCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Cervical Spinal Cord Injury, Respiratory Function Impaired
Keywords
Neural plasticity, Spinal cord injury, Diaphragm, Respiratory training, Spike-timing-dependent plasticity, Neurostimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants with high cervical spinal cord injury will receive 40 treatment sessions (STDP stimulation and respiratory training) and will be asked to complete pre-, Post-20, and Post-40 assessment sessions.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neurostimulation for respiratory function after spinal cord injury
Arm Type
Experimental
Arm Description
Efficacy of STDP on respiratory function.
Intervention Type
Device
Intervention Name(s)
Neurostimulation
Other Intervention Name(s)
Spike-timing-dependent plasticity (STDP stimulation), Neural plasticity
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Repiratory training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Motor evoked potentials (MEPs)
Description
Transcranial magnetic stimuli (TMS) will be delivered to the optimal scalp position for activation of the diaphragm muscle. The optimal scalp position will be determined by moving the coil in small steps along the diaphragm representation of the primary motor cortex to find the region where the largest MEP can be evoked with the minimum intensity in the targeted muscles.
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.
Title
Change in Maximum Voluntary Contractions (MVCs)
Description
Individuals will perform a maximum voluntary contraction (MVC) of diaphragm muscle through surface electrodes secured to the skin over the chest and belly region.
Time Frame
MVCs measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures.
Secondary Outcome Measure Information:
Title
Change in Cervicomedullary electric potentials (CMEPs)
Description
Transcranial magnetic stimuli will be delivered to the optimal position of the cervical spine. A small device on the surface of the skin behind the ear will deliver pulses of electricity over the back of the neck.
Time Frame
CMEPs measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures.
Title
Change in Pulmonary function tests
Description
Spirometry will be tested in upright and supine position to measure negative inspiratory force (NIF), vital capacity (VC), forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and their ration (FEV1/FVC)
Time Frame
Change in pulmonary function tests measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures.
Title
Change in the Diaphragm ultrasound imaging
Description
Ultrasound imaging will be acquired for optimal visualization of each hemidiaphragm. The diaphragm will be examined during quiet breathing and during maximal inspiration. MVCs measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures.
Time Frame
Change in the diaphragm ultrasound imaging measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and females between ages 18-85 years SCI at least 6 months post-injury Spinal Cord injury at C1-C5 Demonstrate respiratory deficit following spinal cord injury as following: (1) Individuals using mechanical ventilation, and (2) individuals with pulmonary function testing (PFT) deficits corresponding to having a vital capacity (VC) < 80% (predicted) Must have a family member or caregiver who is trained and willing to operate the mechanical ventilator during study visits. Exclusion Criteria: Any illness or condition that based on the research team's assessment, will compromise with the participant's ability to comply with the protocol, patient safety, or the validity of the data collected during this study. Any debilitating disease prior to the SCI that caused exercise intolerance. Individuals entirely dependent on the support of a diaphragmatic pacer (24 hours per day). Premorbid, ongoing major depression or psychosis, altered cognitive status. History of head injury or stroke Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication History of seizures or epilepsy Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold Pregnant females If a woman of childbearing age is unsure of the pregnancy, and does not want to take the pregnancy test Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk Metal plate in skull Individuals with scalp shrapnel, cochlear implants, or aneurysm clips Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica A Perez, PT, PhD
Phone
3122382886
Email
mperez04@sralab.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sri Ramya Vemulakonda, M.B.B.S
Phone
3122382993
Email
svemulakon@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica A Perez, PT, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan Ability Lab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sri Ramya Vemulakonda, MBBS
Phone
312-238-2993
Email
svemulakon@sralab.org
First Name & Middle Initial & Last Name & Degree
Monica Perez, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Neurostimulation for Respiratory Function After Spinal Cord Injury

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