Von Willebrand Disease, Type 1VWD/HMBNCT06064851
Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von Willebrand Disease
A study testing Volta System in people with Von Willebrand Disease, Type 1 and Heavy Menstrual Bleeding, run by Five Liters, Inc. at 1 site in United States.
Trial summary
The objectives of this study are to determine if transcutaneous auricular neurostimulation (tAN) can modulate hemostasis, improve perceived quality of life, and improve pain during the menstrual cycle of von Willebrand Disease (VWD) patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Von Willebrand Disease, Type 1, Heavy Menstrual Bleeding
- What is being tested?
- Volta System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2023to 18 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Regularly menstruating female participants between 18-45 years of age
- Typical length of menstruation ranging from 7 to 14 days
- History of menorrhagia as assessed by the Menstrual Bleeding Questionnaire
- For patients who have been diagnoses with von Willebrand Disease Type 1: On hormone therapy (with the exception of Nexplanon- at least three months) and willing to continue use for the duration of the study
- For participants with idiopathic heavy menstrual bleeding: No use of hormon therapy for at least the past three months
- No changes to all current medications and supplements in the past three months, willingness to continue use for duration of study, and not start any new medications or homeopathic remedies
- Reliable access to an Internet-enabled device to complete required questionnaires
- Willingness to consistently use the same brand of tampons and/or pads throughout duration of the study
Who cannot join
- Pregnancy within three months of enrollment
- Lactating at the time of enrollment
- Antifibrinolytic use within 30 days of enrollment
- Acquired bleeding disorder
- Use of anticoagulants (i.e., Aspirin, Warfarin, Coumadin, etc.) including platelet inhibitors for 30 days prior to enrollment
- Use of the Copper intrauterine device within the past 3 months
Show all 15Show fewer
- Known structural cause of heavy menstrual bleeding
- Use of menstrual cups as a method of menstrual blood collection
- Participant has a history of chronic tobacco use or has ingested nicotine via smoking, vaping, smokeless tobacco, or nicotine patches in the past three months
- Participant has received a blood transfusion within 30 days prior to study
- Participant has a history of epileptic seizures
- Participant has a history of neurologic diseases or traumatic brain injury
- Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators)
- Participant has abnormal ear anatomy or ear infection present
- Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study are to determine if transcutaneous auricular neurostimulation (tAN) can modulate hemostasis, improve perceived quality of life, and improve pain during the menstrual cycle of von Willebrand Disease (VWD) patients.
Read the detailed description
This study is designed as an open label, two-arm, decentralized clinical study in which patients with heavy menstrual bleeding (HMB) will receive tAN, which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN). Participants will be enrolled into one of two cohorts of the study over the course of two consecutive menstrual cycles.
- Patients with VWD Type 1 who are on hormone therapy (n=15)
- Patients with no known cause of HMB who are not currently on hormone therapy (n=15)
During the First Menstruation (baseline), no tAN treatment will be delivered. Participants will estimate blood loss daily throughout the duration of the menstruation phase of their first menstrual cycle. Dysmenorrhea, a general quality of life assessment, and total duration of menstruation will be collected on the final day of first menstruation.
During the Second Menstruation, participants will self-administer 2, 1-hour sessions (daily total of 2 hours) of active tAN daily beginning Day 1 of menstruation through the final day of second menstruation. Participants will estimate blood loss daily throughout the duration of the menstruation phase of their second menstruation. Dysmenorrhea, a general quality of life assessment, and total duration of menstruation will be collected on the final day of second menstruation.
- Being tested
- Volta System
- Keywords
- Transcutaneous auricular vagus nerve stimulation, Neurostimulation, Hemostasis, Menstrual cycle, Menstruation, Blood loss, Hormone therapy, PBAC, Menorrhagia, CMSS
- Medical subject headings
- von Willebrand Disease, Type 1, Menorrhagia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volta SystemDevice
The Volta System will be using the components of the Sparrow Ascent device: (FDA-cleared K230796) a wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and/or around the auricle. During Second Menstruation, participants will self-administer 2, 1-hour sessions of active tAN daily with the Volta System Device beginning Day 1 of second menstruation through the final day of second menstruation.
| Study group | Role | What they receive |
|---|---|---|
| Von Willebrand Disease (VWD) Patients | Experimental | Participants with VWD Type 1 who are on hormone therapy. First Menstruation (baseline/no active tAN) followed by Second Menstruation (active tAN) Receives: Device: Volta System |
| Heavy Menstrual Bleeding (HMB) Patients | Experimental | Participants with no known cause of HMB who are not on hormonal therapy. First Menstruation (baseline/no active tAN) followed by Second Menstruation (active tAN) Receives: Device: Volta System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss during menses in both groups
Comparison of mean Pictorial Bleeding Assessment Chart (PBAC) scores during first menstruation (no stimulation) versus second menstruation (active stimulation). The PBAC is a widely accepted tool for patients with HMB to account for menstrual blood loss. Menstrual blood loss is estimated through a selection of images of tampons, pads, clots, and flooding events. Patients mark a tally next to the images that best match each of the menstruation products they used that day. This trial will utilize a modified version of the Wyatt et al. 2001 PBAC, where a tally system will be added to each of the images.
Measured: Daily throughout both menstruations (up to 2 complete menstrual cycles- estimated 60 days)
Quality of Life in both groups
Comparison of mean quality of life score measured by the Short Form 36 (SF-36) during first menstruation (no stimulation) versus second menstruation (active stimulation). The SF-36 is a 36-item patient-reported questionnaire that assesses general quality of life. This questionnaire includes eight variables: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy and vitality, pain, and general perception of health. The SF-36 is scored using a standardized scoring algorithm or by the SF-36 scoring software. The SF-36 scores range from 0 to 100, with higher scores representing better health status.
Measured: Final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)
Duration and severity of dysmenorrhea in both groups
Comparison of mean Cox Menstrual Symptom Scale (CMSS) scores during first menstruation (no stimulation) versus second menstruation (active stimulation). The CMSS measures menstrual distress and dysmenorrhea. The CMSS Severity subscale is an 18-item self-reported scale that measures severity of menstrual symptoms, including pain, nausea, emotions, etc. during menstruation. The CMSS will be used in this trial to measure a participant's dysmenorrhea every day of each menstruation. Each CMSS item is scored from 0-4, with a higher score indicating higher dysmenorrhea severity.
Measured: Final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)
Duration of menstruation in both groups
Compare duration of menstruation between first menstruation (no stimulation) versus second menstruation (active stimulation).
Measured: Final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start27 Oct 2023
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand Disease, Type 1Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants with VWD and HMB will be enrolled in the study over the course of two consecutive menstrual cycles. First Menstruation will be baseline. Second Menstruation participants will self-administer 2, 1-hour sessions of active tAN daily beginning Day 1 of second menstruation through the final day of second menstruation.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Five Liters, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Spark Biomedical, Inc.
- Responsible party
- Sponsor
- Investigators
- Navid Khodaparast, PhD, Principal investigator, Chief Science OfficerMelanie McWade, PhD, Study director, Senior Director of Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064851
- Sponsor's protocol ID
- 5L-BLD-05
- Acronym
- VWD/HMB
- Status last verified
- Apr 2025
- First submitted
- 15 Sep 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von Willebrand Disease
- ClinicalTrials.gov ID
- NCT06064851
- Acronym / sponsor ID
- VWD/HMB / 5L-BLD-05
- Keywords
- Transcutaneous auricular vagus nerve stimulation, Neurostimulation, Hemostasis, Menstrual cycle, Menstruation, Blood loss, Hormone therapy, PBAC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Five Liters, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Spark Biomedical, Inc.
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 3 Oct 2023 (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 objectives of this study are to determine if transcutaneous auricular neurostimulation (tAN) can modulate hemostasis, improve perceived quality of life, and improve pain during the menstrual cycle of von Willebrand Disease (VWD) patients.
Detailed description
This study is designed as an open label, two-arm, decentralized clinical study in which patients with heavy menstrual bleeding (HMB) will receive tAN, which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN). Participants will be enrolled into one of two cohorts of the study over the course of two consecutive menstrual cycles.
- Patients with VWD Type 1 who are on hormone therapy (n=15)
- Patients with no known cause of HMB who are not currently on hormone therapy (n=15)
During the First Menstruation (baseline), no tAN treatment will be delivered. Participants will estimate blood loss daily throughout the duration of the menstruation phase of their first menstrual cycle. Dysmenorrhea, a general quality of life assessment, and total duration of menstruation will be collected on the final day of first menstruation.
During the Second Menstruation, participants will self-administer 2, 1-hour sessions (daily total of 2 hours) of active tAN daily beginning Day 1 of menstruation through the final day of second menstruation. Participants will estimate blood loss daily throughout the duration of the menstruation phase of their second menstruation. Dysmenorrhea, a general quality of life assessment, and total duration of menstruation will be collected on the final day of second menstruation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with VWD and HMB will be enrolled in the study over the course of two consecutive menstrual cycles. First Menstruation will be baseline. Second Menstruation participants will self-administer 2, 1-hour sessions of active tAN daily beginning Day 1 of second menstruation through the final day of second menstruation.
| Arm | Type | Receives |
|---|---|---|
| Von Willebrand Disease (VWD) Patients | Experimental | Device: Volta SystemParticipants with VWD Type 1 who are on hormone therapy. First Menstruation (baseline/no active tAN) followed by Second Menstruation (active tAN) |
| Heavy Menstrual Bleeding (HMB) Patients | Experimental | Device: Volta SystemParticipants with no known cause of HMB who are not on hormonal therapy. First Menstruation (baseline/no active tAN) followed by Second Menstruation (active tAN) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Regularly menstruating female participants between 18-45 years of age
- Typical length of menstruation ranging from 7 to 14 days
- History of menorrhagia as assessed by the Menstrual Bleeding Questionnaire
- For patients who have been diagnoses with von Willebrand Disease Type 1: On hormone therapy (with the exception of Nexplanon- at least three months) and willing to continue use for the duration of the study
- For participants with idiopathic heavy menstrual bleeding: No use of hormon therapy for at least the past three months
Key exclusion criteria (15 listed)
- Pregnancy within three months of enrollment
- Lactating at the time of enrollment
- Antifibrinolytic use within 30 days of enrollment
- Acquired bleeding disorder
- Use of anticoagulants (i.e., Aspirin, Warfarin, Coumadin, etc.) including platelet inhibitors for 30 days prior to enrollment
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 |
|---|---|---|
| Volta SystemThe Volta System will be using the components of the Sparrow Ascent device: (FDA-cleared K230796) a wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and/or around the auricle. During Second Menstruation, participants will self-administer 2, 1-hour sessions of active tAN daily with the Volta System Device beginning Day 1 of second menstruation through the final day of second menstruation. | Device | Heavy Menstrual Bleeding (HMB) Patients, Von Willebrand Disease (VWD) Patients |
Primary outcome
Blood loss during menses in both groups
Time frame: Daily throughout both menstruations (up to 2 complete menstrual cycles- estimated 60 days)
Comparison of mean Pictorial Bleeding Assessment Chart (PBAC) scores during first menstruation (no stimulation) versus second menstruation (active stimulation). The PBAC is a widely accepted tool for patients with HMB to account for menstrual blood loss. Menstrual blood loss is estimated through a selection of images of tampons, pads, clots, and flooding events. Patients mark a tally next to the images that best match each of the menstruation products they used that day. This trial will utilize a modified version of the Wyatt et al. 2001 PBAC, where a tally system will be added to each of the images.
Quality of Life in both groups
Time frame: Final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)
Comparison of mean quality of life score measured by the Short Form 36 (SF-36) during first menstruation (no stimulation) versus second menstruation (active stimulation). The SF-36 is a 36-item patient-reported questionnaire that assesses general quality of life. This questionnaire includes eight variables: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy and vitality, pain, and general perception of health. The SF-36 is scored using a standardized scoring algorithm or by the SF-36 scoring software. The SF-36 scores range from 0 to 100, with higher scores representing better health status.
Duration and severity of dysmenorrhea in both groups
Time frame: Final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)
Comparison of mean Cox Menstrual Symptom Scale (CMSS) scores during first menstruation (no stimulation) versus second menstruation (active stimulation). The CMSS measures menstrual distress and dysmenorrhea. The CMSS Severity subscale is an 18-item self-reported scale that measures severity of menstrual symptoms, including pain, nausea, emotions, etc. during menstruation. The CMSS will be used in this trial to measure a participant's dysmenorrhea every day of each menstruation. Each CMSS item is scored from 0-4, with a higher score indicating higher dysmenorrhea severity.
Duration of menstruation in both groups
Time frame: Final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)
Compare duration of menstruation between first menstruation (no stimulation) versus second menstruation (active stimulation).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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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. This study is not recruiting at the moment.
Navid Khodaparast, PhD principal investigator
Chief Science Officer
Melanie McWade, PhD study director
Senior Director of Clinical Operations
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volta System in people with Von Willebrand Disease, Type 1 and Heavy Menstrual Bleeding, run by Five Liters, Inc. 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 8 inclusion and 15 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: finished, as of the sponsor's last update on 27 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss during menses in both groups (time frame: Daily throughout both menstruations (up to 2 complete menstrual cycles- estimated 60 days)). The study lists 4 primary outcomes in all. 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 27 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.