protocolSection identificationModule nctId: NCT06324344, orgStudyIdInfo id: H-50753-B, briefTitle: Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-02, primaryCompletionDateStruct date: 2025-10-02, completionDateStruct date: 2025-10-02, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Baylor College of Medicine, class: OTHER, collaborators name: NeuroMetrix, Inc., descriptionModule briefSummary: The purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless Transcutaneous Electrical Nerve Stimulation (TENS) technology to address Chemotherapy Induced Peripheral Neuropathy (CIPN). Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. The patients and clinicians will be blinded for group allocation. One group will utilize TENS high-dose devices (Intervention group, IG); the other group will utilize low-dose TENS devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 8 weeks. Then, the patients will come back after four weeks (4W) and after 8 weeks (8W) for outcome assessment. The primary outcome will be pain. Secondary outcomes include: nerve conduction and velocity, vibration perception threshold, quality of life. Exploratory outcomes include gait assessment (gait speed, stride length, double stance, and gait steadiness), and balance., conditionsModule conditions: Chemotherapy-induced Peripheral Neuropathy, conditions: Pain, conditions: Neuropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned into two groups in a 1:1 ratio. One group will utilize high-dose TENS therapy (Intervention group, AG); the other group will utilize low-dose TENS devices (Placebo group, PG).Both groups will receive their respective devices at the initial visit (Baseline) and will be asked to return in 4 weeks and 8 weeks for follow-up assessment.Throughout this 8-week period the participants may receive follow-up phone calls assessing their compliance. All subjects will keep their active device after completion of the 8-week study., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Double, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: High-Dose TENS, interventions name: Low-Dose TENS, outcomesModule primaryOutcomes measure: Change in pain level at 8 weeks from baseline, secondaryOutcomes measure: Change in vibration perception threshold at 8 weeks from baseline, secondaryOutcomes measure: Change in sural nerve conduction velocity and amplitude at 8 weeks from baseline, secondaryOutcomes measure: Changes in Quality of Life at 8 weeks from baseline, otherOutcomes measure: Changes in stride time at 8 weeks from baseline, otherOutcomes measure: Changes in cadence at 8 weeks from baseline, otherOutcomes measure: Changes in double-support phase at 8 weeks from baseline, otherOutcomes measure: Changes in Range of Motion (RoM) at 8 weeks from baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baylor College of Medicine, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Bijan Najafi, PhD, role: CONTACT, phone: 713-798-7536, email: bijan.najafi@bcm.edu, contacts name: Maria Noun, BS, role: CONTACT, phone: 713-798-7538, email: maria.noun@bcm.edu, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False