## Protocol Section
### Identification Module
**NCT ID:** NCT06272279

**Brief Title:** Neuromodulation With Spinal Stimulation Methods

**Official Title:** Neuromodulation With Spinal Stimulation Methods

#### Organization Study ID Info
**ID:** HS23666(B2020:015)
#### Organization
**Class:** OTHER
**Full Name:** University of Manitoba
### Status Module
#### Completion Date
**Date:** 2025-02-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2024-02-22
**Type:** ACTUAL
**Study First Submit Date:** 2021-03-09
**Study First Submit QC Date:** 2024-02-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Manitoba

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (SCI). Up to 24 participants will be enrolled. A variety of stimulation parameters and outcome measures will be assessed.

**Detailed Description:** Purpose of this project

Spinal cord stimulation has the potential to improve motor function recovery after spinal cord injury. Commonly used approaches include low-intensity, direct current (DC) stimulation applied across multiple segments, electrical transcutaneous (ETC) stimulation, and magnetic transcutaneous stimulation (MTC).

Objective: to evaluate and compare the voluntary and reflexive motor performance in the same subjects, including people with and without spinal cord injury, after non-invasive spinal cord stimulation interventions. Comparing two different interventions applied in different experimental sessions and the respective sham stimulation is the goal of this study.

corticospinal and spinal motor pathways in paraplegics and in non-injured humans will be tested.

### Conditions Module

**Conditions:**

- Spinal Cord Injuries

- Spinal Cord Injury at C5-C7 Level

- Paraplegia, Spinal

- Paraplegia, Incomplete

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** Semi-blinded, randomized block entry design, crossover intervention study.

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** The participant will be connected to the stimulation device(s) but will not know if it has been turned on during each trial. In addition, the person analyzing the outcome data will not be aware of the stimulation status of the participant.

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 24

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Spinal cord stimulation will be administered to participants for 15 min.

**Intervention Names:**

- Device: spinal stimulation-DCS

- Other: spinal stimulation-EPS

**Label:** Spinal cord stimulation

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Sham spinal cord stimulation will be administered to participants for 15 min.

**Intervention Names:**

- Other: spinal stimulation-sham DCS

- Other: sham spinal stimulation-EPS

**Label:** Shamspinal cord stimulation

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Spinal cord stimulation

**Description:** transcutaneous spinal stimulation by direct current stimulation

**Name:** spinal stimulation-DCS

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Shamspinal cord stimulation

**Description:** sham transcutaneous spinal stimulation by direct current stimulation

**Name:** spinal stimulation-sham DCS

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Spinal cord stimulation

**Description:** transcutaneous spinal stimulation by electrical pulsed stimulation

**Name:** spinal stimulation-EPS

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Shamspinal cord stimulation

**Description:** sham transcutaneous spinal stimulation by electrical pulsed stimulation

**Name:** sham spinal stimulation-EPS

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** H-reflex input output curve

**Measure:** Motor response

**Time Frame:** Immediately after stimulation (within 1-15 min)

**Description:** MEP input-output curve

**Measure:** Motor evoked potentials

**Time Frame:** Immediately after stimulation (within 1-15 min)

#### Secondary Outcomes

**Description:** Perception of discomfort due to stimulation

**Measure:** Blood pressure

**Time Frame:** During procedure

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* spinal cord injury C4 to L4
* ability to understand and follow directions

Exclusion Criteria:

* history of seizures, head injury, concussion, unexplained loss of consciousness or if they lived with an implanted cochlear stimulator, brain/neurostimulator, cardiac pacemaker, medication infusion device or live with metal implants in their body or if they are pregnant.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** katinka.stecina@umanitoba.ca

**Name:** Katinka Stecina, PhD

**Phone:** 204 789 3761

**Role:** CONTACT

**Contact 2:**

**Email:** kristine.cowley@umanitoba.ca

**Name:** Kristine Cowley, PhD

**Phone:** 2047893305

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Winnipeg

**Country:** Canada

**Facility:** University of Manitoba

**State:** Manitoba

**Status:** ENROLLING_BY_INVITATION

**Zip:** R3E 0J9

**Location 2:**

**City:** Winnipeg

**Contacts:**

***Contact 1:***

- **Email:** Katinka.Stecina@umanitoba.ca

- **Name:** Katinka Stecina, Ph.D.

- **Phone:** 2047893761

- **Role:** CONTACT

***Contact 2:***

- **Email:** Kristine.Cowley@umanitoba.ca

- **Name:** Kristine Cowley, Ph.D.

- **Phone:** 2047893305

- **Role:** CONTACT

**Country:** Canada

**Facility:** University of Manitoba

**State:** Manitoba

**Status:** RECRUITING

**Zip:** R3E 0J9

### IPD Sharing Statement Module

**Access Criteria:** Upon request

**Description:** Upon request, we will consider making anonymized data available for analysis by other researchers

**Info Types:**

- STUDY_PROTOCOL

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** After study completion (May 2022) for one year.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000010243

- Term: Paralysis

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15916

- Name: Spinal Cord Injuries

- Relevance: HIGH

- As Found: Spinal Cord Injury

- ID: M13177

- Name: Paraplegia

- Relevance: HIGH

- As Found: Paraplegia

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M13157

- Name: Paralysis

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T4421

- Name: Paraplegia

- Relevance: HIGH

- As Found: Paraplegia

### Condition Browse Module - Meshes

- ID: D000013119

- Term: Spinal Cord Injuries

- ID: D000010264

- Term: Paraplegia

- ID: D000014947

- Term: Wounds and Injuries

### Misc Info Module

- Version Holder: 2024-05-24
