## Protocol Section
### Identification Module
**NCT ID:** NCT02331979

**Brief Title:** Improving Bladder Function in SCI by Neuromodulation

**Official Title:** Improving Bladder Function in SCI by Neuromodulation

#### Organization Study ID Info
**ID:** 14-000932
#### Organization
**Class:** OTHER
**Full Name:** University of California, Los Angeles
### Status Module
#### Completion Date
**Date:** 2024-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-05-19

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-09

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2015-01-06
**Type:** ESTIMATED
**Study First Submit Date:** 2015-01-03
**Study First Submit QC Date:** 2015-01-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, Los Angeles

#### Responsible Party

**Investigator Affiliation:** University of California, Los Angeles

**Investigator Full Name:** Daniel Lu, MD, PhD

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of spinal cord injury.

**Detailed Description:** This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of spinal cord injury. Neuromodulation will be in the form of transcutaneous electrical stimulation and/or magnetic stimulation.

### Conditions Module

**Conditions:**

- Spinal Cord Injury

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 24

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Evaluate neuromodulation in 6 subjects with prior motor training.

**Intervention Names:**

- Device: Electromagnetic Neuromodulation

**Label:** Stimulation of Non-Naive

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Evaluate neuromodulation in 6 naive subjects.

**Intervention Names:**

- Device: Electromagnetic Neuromodulation

**Label:** Stimulation of Naive

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Apply parameters discovered in Arm 1 and Arm 2 to evaluate neuromodulation in 12 naive subjects.

**Intervention Names:**

- Device: Electromagnetic Neuromodulation

**Label:** Stimulation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Stimulation

- Stimulation of Naive

- Stimulation of Non-Naive

**Description:** Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.

**Name:** Electromagnetic Neuromodulation

**Other Names:**

- Transcutaneous Electrical Stimulation

- Magnetic Stimulation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Urine flow and volume

**Time Frame:** Months 1-48

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Male 18-45 years;
2. At least 1 year post-injury;
3. Non-progressive SCI at C2-T8 (non-conus injury);
4. Motor Complete ASIA (A or B);
5. Neurogenic bladder requiring clean intermittent straight catheterization;
6. Able to attend twice weekly testing sessions for 6 months.
7. Have intact lower extremity anatomy and able to use lower extremity for assistive standing and stepping.

Exclusion Criteria:

1. History of autonomic dysreflexia;
2. Ventilator dependency;
3. Musculoskeletal dysfunction, unhealed fracture, pressure ulcer, active infection;
4. Clinically significant depression or ongoing drug abuse;
5. Received botox injection, or bladder surgery (suprapubic access, Brindley procedure, etc.); 6. Prostatic hypertrophy or bladder outlet disorder;

7. Cardiopulmonary disease that precludes lower extremity training or rehabilitation.

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dclu@mednet.ucla.edu

**Name:** Daniel Lu, MD PhD

**Phone:** 310-825-4321

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Los Angeles

**Contacts:**

***Contact 1:***

- **Email:** dclu@mednet.ucla.edu

- **Name:** Daniel C Lu, MD PhD

- **Phone:** 310-267-2975

- **Role:** CONTACT

**Country:** United States

**Facility:** University of California, Los Angeles

**State:** California

**Status:** RECRUITING

**Zip:** 90095

## 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: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15916

- Name: Spinal Cord Injuries

- Relevance: HIGH

- As Found: Spinal Cord 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: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013119

- Term: Spinal Cord Injuries

### Misc Info Module

- Version Holder: 2024-05-24
