Vibratory Genital Nerve Stimulation to Help Female Sexual Function After Spinal Cord Injury
Official title: Advancing Sexual Health in Spinal Cord Injury: Evaluation of Vibratory Genital Nerve Stimulation
Run by Hennepin Healthcare Research Institute · NCT07870642 · Data updated 2026-11-12
This study tests whether a home-use vibration device can improve sexual function in cisgender women with spinal cord injury by increasing genital blood flow during arousal.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | Hennepin Healthcare Research Institute Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | September 2026 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07870642 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are cisgender women aged 18–65 with chronic spinal cord injury and self-reported sexual function impairment who can independently operate the Lioness device.
✕Probably not a fit
Individuals who do not experience vascular or neural responses to vGNS or have contraindications may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial uses in-clinic arousal assessments with a vGNS session and non-invasive blood flow imaging, followed by 12 weeks of twice-weekly home vibration therapy with the Lioness device, and periodic questionnaires to track changes in sexual function.
Why it matters
Potential benefit: If successful, participants may experience improvements in sexual arousal and function.
How similar studies have gone: Prior research on neuromodulation for sexual function shows potential benefits in related conditions, but this exact approach is novel for FSD after SCI.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
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Hennepin Healthcare Research Institute
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Study coordinator: Study Coordinator
- Email: rnl@umn.edu
- Phone: 612-873-9113
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.