Improving Bladder Function in SCI by Neuromodulation

University of California, Los Angeles (UCLA)

Status: Enrolling

Conditions: Spinal Cord Injury

Treatments: Device: Electromagnetic Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02331979

14-000932

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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;

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Stimulation of Non-Naive

Experimental group

Description:

Evaluate neuromodulation in 6 subjects with prior motor training.

Treatment:

Device: Electromagnetic Neuromodulation

Stimulation of Naive

Experimental group

Description:

Evaluate neuromodulation in 6 naive subjects.

Treatment:

Device: Electromagnetic Neuromodulation

Stimulation

Experimental group

Description:

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

Treatment:

Device: Electromagnetic Neuromodulation