Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT06932302
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
At-Home Neuromodulation for Female Sexual Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of dorsal genital nerve stimulation (DGS) sessions performed', 'timeFrame': 'Approximately day 22'}, {'measure': 'Number of related adverse events', 'timeFrame': 'Up to week 9', 'description': 'Study-related AEs include incidents such as device zapping, skin irritation, back cramps, or falls due to sitting for 30 minutes of stimulation.'}], 'secondaryOutcomes': [{'measure': 'Change in Female Sexual Function Index (FSFI) total scores', 'timeFrame': 'Baseline and approximately day 22', 'description': 'The FSFI is a 19-question survey assessing sexual function in 6 different domains (desire, arousal, lubrication, orgasm, satisfaction, and pain). Each question asks subjects to rate an aspect of their sexual function on a scale from 0 or 1 to 5, depending on the question. The total score for each subdomain is multiplied by a factor so that the maximum score is 6. The total score is out of 36, with the cutoff score for overall dysfunction being 26.55. Subdomain scores of 3 or less indicate dysfunction in the respective subdomain. The FSFI will be conducted before the first study visit and again within one week after completion of the at-home stimulation period in order to see if scores have changed over the course of the treatment.'}, {'measure': 'The Patient Global Impression of Change (PGIC) survey score', 'timeFrame': 'Up to week 9', 'description': 'The Patient Global Impression of Change (PGIC) is a 1-question survey asking patients to describe the change in their condition with a number from 1 to 7. Each number is paired with a description, where 1 represents "No change (or condition is worse)" and 7 represents "A great deal better, and a considerable improvement that has made all the difference". The PGIC will be administered within one week after completion of at-home stimulation, and again 1 month later in order to assess the patient\'s perception of their change in symptoms.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dorsal genital nerve stimulation', 'neuromodulation'], 'conditions': ['Female Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'This pilot study investigates the regular use of non-invasive dorsal genital nerve stimulation (DGS) for the treatment of female sexual dysfunction (FSD). The researchers aim to determine whether subjects with FSD can correctly follow an at-home treatment regimen and to demonstrate that DGS can improve FSD arousal symptoms in premenopausal and postmenopausal women. Some subjects will use a smart vibrator for comparison to DGS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capable of speaking and understanding English.\n* Able to comprehend the clinical study procedures and provide informed consent.\n* Identified as having female sexual dysfunction with a Female Sexual Function Index (FSFI) score of 26.55 or less and a score of 3 or less on one or more of the FSFI subdomains of lubrication, arousal, and orgasm.\n* Willing and able to adhere to the study protocol\n* Able to attend experimental sessions at Michigan Medicine at both the start and conclusion of the study.\n\nExclusion Criteria:\n\n* Not currently sexually active.\n* Pregnant or planning to get pregnant during the study period.\n* History of a neurological disorder or impairments affecting pelvic organ function, including diagnosed with dorsal genital nerve damage, lower motor dysfunction, or other related conditions.\n* Implanted with a neurostimulator for bladder or bowel function.\n* Have a skin condition that would predispose them to sensitivity to the stimulation electrodes.\n* Female sexual dysfunction limited solely to low desire, without issues in lubrication, arousal, or orgasm.\n* Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms; or a score of 8 or higher on the American Urological Association Symptom Index (AUASI).\n* Unable or unwilling to adhere to the study protocol\n* Simultaneously participating in another research study that may affect the results of this study.'}, 'identificationModule': {'nctId': 'NCT06932302', 'briefTitle': 'At-Home Neuromodulation for Female Sexual Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'At-Home Neuromodulation for Female Sexual Dysfunction', 'orgStudyIdInfo': {'id': 'HUM00265573'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nerve Stimulation only', 'description': 'Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only perform dorsal genital nerve stimulation.', 'interventionNames': ['Device: Electrical Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Nerve Stimulation and Vibration', 'description': 'Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will perform dorsal genital nerve stimulation and use a smart vibrator.', 'interventionNames': ['Device: Electrical Stimulation', 'Device: Smart vibrator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vibration only', 'description': 'Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only use a smart vibrator.', 'interventionNames': ['Device: Smart vibrator']}], 'interventions': [{'name': 'Electrical Stimulation', 'type': 'DEVICE', 'otherNames': ['UCon patch system'], 'description': 'Electrical stimulation of the dorsal genital nerve will be accomplished using the UCon system and patch electrodes developed by InnoCon. The UCon system includes a programmable control unit; leads that connect to the control unit and electrodes; a silicone surface electrode; a reference electrode; and a remote control for quick on and off toggling of stimulation.', 'armGroupLabels': ['Nerve Stimulation and Vibration', 'Nerve Stimulation only']}, {'name': 'Smart vibrator', 'type': 'DEVICE', 'description': 'Subjects will use a smart vibrator at home twice a week during the study. The Lioness smart vibrator records physiological responses during use.', 'armGroupLabels': ['Nerve Stimulation and Vibration', 'Vibration only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yike Liu', 'role': 'CONTACT', 'email': 'yikel@umich.edu', 'phone': '734-647-8568'}, {'name': 'Tim Bruns, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Priyanka Gupta, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Yike Liu', 'role': 'CONTACT', 'email': 'yikel@umich.edu', 'phone': '734-647-8568'}, {'name': 'Tim Bruns, PhD', 'role': 'CONTACT', 'email': 'bruns@umich.edu', 'phone': '734-647-8727'}], 'overallOfficials': [{'name': 'Tim Bruns, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Priyanka Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Biomedical Engineering', 'investigatorFullName': 'Timothy Bruns', 'investigatorAffiliation': 'University of Michigan'}}}}