ClinicalTrials.gg
Sign In
RecruitingNCT07870642Updated Oct 13, 2026

Vibratory Genital Nerve Stimulation (vGNS) to Treat Female Sexual Dysfunction (FSD) After Spinal Cord Injury (SCI)

An interventional study of Vibratory genital nerve stimulation in Spinal Cord Injury and Sexual Dysfunction Female, sponsored by Samuel Cramer. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Samuel Cramer · Not applicable, Interventional, and Treatment

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Spinal Cord Injury
  • Sexual Dysfunction Female
03

In context

Spinal Cord Injuries

1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.

This study's planned enrollment of 20 is below the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Samuel Cramer is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Active vibratory genital nerve stimulation (vGNS)

    Device: Vibratory genital nerve stimulation

Interventions

  • DeviceVibratory genital nerve stimulation

    vGNS will be administered in this study via the Lioness vibrator

06

What researchers measure

Primary outcomes

  1. Change in genital blood perfusion during acute vibratory genital nerve stimulation (vGNS)

    Change in LSCI-measured genital blood perfusion during a standardized psychogenic sexual arousal assessment (PSAA) before and after an in-clinic vGNS block in women with spinal cord injury.

    Time frame: 2-3 hours

07

Study locations

1 of 1 sites recruiting
  • Hennepin Healthcare Research Institute
    Minneapolis, Minnesota 55415, United States
    • Study Coordinator · Contact · rnl@umn.edu · 612-873-9113
    Recruiting
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 15, 2026

Documents are hosted by the registry — open the source record to download them.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jul 2028, 22 months later.

Of 766 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 22 months is below that.

Counting every sponsor, half of 816 studies reached it within 35 months; a quarter within 16 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 13, 2026
StartEst.
Sep 2026
Primary completionEst.
Jul 2028
CompletionEst.
Jul 2028
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07870642
Lead sponsor
Samuel Cramer
Responsible party
Samuel Cramer (Principle Investigator, Hennepin Healthcare Research Institute) — Sponsor-investigator
First posted
Oct 13, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Study Coordinator
Contact
rnl@umn.edu
612-873-9113

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Spinal Cord Injuries →

Other studies from this sponsor

Samuel Cramer

Start the discussion