Spinal Cord InjuryNCT07870642
Vibratory Genital Nerve Stimulation (vGNS) to Treat Female Sexual Dysfunction (FSD) After Spinal Cord Injury (SCI)
A study testing Vibratory genital nerve stimulation in people with Spinal Cord Injury and Sexual Dysfunction Female, run by Samuel Cramer at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Spinal Cord Injury, Sexual Dysfunction Female
- What is being tested?
- Vibratory genital nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415
Study Coordinator, 612-873-9113, rnl@umn.edu
About this study
Official title: Advancing Sexual Health in Spinal Cord Injury: Evaluation of Vibratory Genital Nerve Stimulation
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?
Read more
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
- Being tested
- Vibratory genital nerve stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibratory genital nerve stimulationDevice
vGNS will be administered in this study via the Lioness vibrator
| Study group | Role | What they receive |
|---|---|---|
| Active vibratory genital nerve stimulation (vGNS) | Experimental | Not described Receives: Device: Vibratory genital nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Cramer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samuel Cramer, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870642
- Sponsor's protocol ID
- IRB-FY2026-1245
- Other IDs
- 1529666
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Sexual Health in Spinal Cord Injury: Evaluation of Vibratory Genital Nerve Stimulation
- ClinicalTrials.gov ID
- NCT07870642
- Acronym / sponsor ID
- IRB-FY2026-1245
- Conditions
- Spinal Cord Injury, Sexual Dysfunction Female
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Samuel CramerUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active vibratory genital nerve stimulation (vGNS) | Experimental | Device: Vibratory genital nerve stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibratory genital nerve stimulationvGNS will be administered in this study via the Lioness vibrator | Device | Active vibratory genital nerve stimulation (vGNS) |
Primary outcome
Change in genital blood perfusion during acute vibratory genital nerve stimulation (vGNS)
Time frame: 2-3 hours
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibratory genital nerve stimulation in people with Spinal Cord Injury and Sexual Dysfunction Female, run by Samuel Cramer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (612-873-9113, rnl@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in genital blood perfusion during acute vibratory genital nerve stimulation (vGNS) (time frame: 2-3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.