Recruiting

vGNS

Sponsor:

Samuel Cramer

Code:

NCT07870642

Conditions

Spinal Cord Injury

Sexual Dysfunction Female

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Vibratory genital nerve stimulation

Study Details

Brief summary:

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

Conditions

Spinal Cord Injury

Sexual Dysfunction Female

Study ID

NCT07870642

Start date

Sep, 2026

Status verified date

Oct, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active vibratory genital nerve stimulation (vGNS)

Interventions

Vibratory genital nerve stimulation

vGNS will be administered in this study via the Lioness vibrator

Primary outcome measure

  • Change in genital blood perfusion during acute vibratory genital nerve stimulation (vGNS) [ Time Frame: 2-3 hours ]

Central Contacts and Locations

Central contacts

Study Coordinator

612-873-9113rnl@umn.edu

Locations

Hennepin Healthcare Research Institute

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Study Coordinator

612-873-9113rnl@umn.edu

More Information

Sponsor

Samuel Cramer

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Samuel Cramer on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.