What this study is
The goal of this clinical trial is to learn if vibratory genital nerve stimulation (vGNS) can improve sexual function in women with spinal cord injury. The main question it aims to answer is:
Does acute vGNS increase genital blood flow during a standardized sexual arousal assessment, as measured by laser speckle contrast imaging?
Participants will:
Complete a baseline in-clinic visit including two sexual arousal assessments with a vGNS session in between, while genital blood flow is measured using a non-invasive imaging device
Use a vibration device at home twice weekly for 12 weeks
Complete questionnaires about sexual function at baseline, during the home phase, and at a 12-week follow-up visit
Attend a follow-up in-clinic visit repeating the baseline assessments
What's being tested
- Vibratory genital nerve stimulation
Intervention · DEVICE
vGNS will be administered in this study via the Lioness vibrator
Study details
- Official title
- Advancing Sexual Health in Spinal Cord Injury: Evaluation of Vibratory Genital Nerve Stimulation
- Sponsor
- Samuel Cramer
- Conditions
- Spinal Cord Injury · Sexual Dysfunction Female
- Enrolling
- 20 people
- Starts
- 2026-09
- Est. completion
- 2028-07
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Be cisgender women aged 18 to 65 years (current study is scoped specifically to cisgender female anatomy)
- Have a chronic (> 1 year) spinal cord injury
- Self-report impaired sexual function (e.g., arousal, lubrication, orgasm)
- Be sexually active or report a desire for sexual activity
- Be able to place and operate the Lioness device independently
- Be able to provide informed consent and participate in study procedures
You can't join if
- Are currently pregnant or attempting to become pregnant
- Have a history of autonomic dysreflexia (AD) triggered by sexual activity or genital stimulation
- Have undergone pelvic reconstructive surgery
- Report being unable to independently position and operate the Lioness device due to motor or anatomical limitations
- Have a recent history of urinary tract infection, vaginal infection, or active genital skin condition within the last 3 months
- Have implanted medical devices or cardiovascular instability that contraindicates vibratory stimulation (e.g., pacemaker)
- Are currently taking medications that may influence sexual arousal response in the opinion of the investigator
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openHennepin Healthcare Research Institute
Minneapolis, Minnesota, United States
- Study Coordinator · Contact612-873-9113rnl@umn.edu
Recruiting
Study team
Sponsor
Samuel Cramer
Study ID IRB-FY2026-1245
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.