Improving Bladder Function in SCI by Neuromodulation

NCT ID: NCT02331979

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2026-01-31

Brief Summary

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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

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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

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Spinal Cord Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stimulation of Non-Naive

Evaluate neuromodulation in 6 subjects with prior motor training.

Group Type EXPERIMENTAL

Electromagnetic Neuromodulation

Intervention Type DEVICE

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

Stimulation of Naive

Evaluate neuromodulation in 6 naive subjects.

Group Type EXPERIMENTAL

Electromagnetic Neuromodulation

Intervention Type DEVICE

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

Stimulation

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

Group Type EXPERIMENTAL

Electromagnetic Neuromodulation

Intervention Type DEVICE

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

Interventions

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Electromagnetic Neuromodulation

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

Intervention Type DEVICE

Other Intervention Names

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Transcutaneous Electrical Stimulation Magnetic Stimulation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Daniel Lu, MD, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel Lu, MD PhD

Role: CONTACT

310-825-4321

Facility Contacts

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Daniel C Lu, MD PhD

Role: primary

310-267-2975

Other Identifiers

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14-000932

Identifier Type: -

Identifier Source: org_study_id

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