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All Federal Grant Awards
Project Grant R44NS117294
Award Date
5/1/20
Completion Date
4/30/28
Dollars Obligated
$5.9M
Overview
Activity
11
Transactions
11
Subawards
Similar Awards
Federal Agency
National Institute of Neurological Disorders and Stroke
Awardee
Noctrix Health Inc. (HZ6HVKF5M8D6)
Federal Grant Program
93.853
Assistance Type
Project Grant
Place of Performance
Pleasanton, CA 94566, USA
Update #1
Update #2
TREATMENT OF RESTLESS LEGS SYNDROME THROUGH NON-INVASIVE PERIPHERAL NERVE STIMULATION
Posted 4/20/20
5
1
2
3
Mod #
Description
ReasonForModification
Federal Obligation
Date
Not listed
DEVELOPING CLOSED-LOOP TONIC MOTOR ACTIVATION THERAPY FOR TREATMENT OF REFRACTORY RESTLESS LEGS SYNDROME - SUMMARY: RESTLESS LEGS SYNDROME (RLS) IS A PREVALENT AND DEBILITATING SLEEP DISORDER THAT AFFECTS A SIGNIFICANT PORTION OF THE ADULT POPULATION, LEADING TO CONSIDERABLE SLEEP DEPRIVATION AND A REDUCTION IN QUALITY OF LIFE. CURRENT TREATMENTS FOR RLS PROVIDE MIXED RESULTS AND, IN THE CASE OF MEDICATIONS, UNDESIRABLE SIDE EFFECTS. THE NEED FOR INNOVATIVE SOLUTIONS IS CLEAR. THE NOCTRIX TONIC MOTOR ACTIVATION SYSTEM (TOMAC) REPRESENTS A NOVEL APPROACH TO RLS MANAGEMENT THROUGH NON-INVASIVE PERIPHERAL NERVE STIMULATION, OFFERING A PROMISING ALTERNATIVE TO TRADI- TIONAL THERAPIES. DESPITE THE SUCCESS OF TOMAC 1.0 IN REDUCING RLS SYMPTOMS, CHALLENGES REMAIN IN REDUCING SLEEP FRAGMENTATION AND FACILITATING MEDICATION REDUCTION. THE PROPOSED SBIR PHASE IIB PROJECT AIMS TO DEVELOP AND CLINICALLY VALIDATE A CLOSED-LOOP VERSION OF TOMAC (CL-TOMAC) TO ADDRESS THESE UNMET NEEDS. CL-TOMAC WILL USE LEG MOVEMENT DETECTION ALGORITHMS DEVELOPED IN THE PRIOR SBIR PHASE II TO AUTOMATICALLY ACTIVATE THERAPY DURING SLEEP TO REDUCE WAKE AFTER SLEEP ONSET (WASO). ADDITIONALLY, CL-TOMAC WILL FACILITATE REDUCTION IN THE DOSAGE OF COMMON RLS MEDICATIONS (DOPAMINERGICS AND OPIOIDS), ALLEVIATING THE SIDE EFFECTS ASSOCIATED WITH LONG-TERM MEDICATION USE. THE PROJECT IS STRUCTURED AROUND THREE SPECIFIC AIMS: 1) DEVELOP AND VERIFY A CLOSED- LOOP STIMULATION ALGORITHM THAT IS SENSITIVE AND SPECIFIC IN DETECTING THE NEED FOR ACTIVATION DURING SLEEP, 2) ASSESS THE FEASIBILITY OF CL-TOMAC IN REDUCING WASO IN PATIENTS WITH REFRACTORY RLS, AND 3) EVALUATE THE POTENTIAL OF CL-TOMAC TO FACILITATE REDUCTIONS IN COMMON RLS MEDICATION DOSAGES. SUCCESS WILL BE MEASURED THROUGH RIGOROUS CLINICAL AND TECHNICAL VALIDATION PROCESSES, INCLUDING POLYSOMNOGRAPHY, ACTIGRAPHY, AND MEDICATION DOS- AGE ASSESSMENTS. BY ADDRESSING THESE CRITICAL CHALLENGES, CL-TOMAC PROMISES TO IMPROVE HEALTH OUTCOMES AND ENHANCE QUALITY OF LIFE FOR THOSE AFFECTED BY RLS. FOLLOWING SUCCESSFUL COMPLETION, THE RESULTS OF AIMS 2-3 WILL DETERMINE THE INTENDED USE FOR CL-TOMAC (EXPANDED TO INCLUDE MEDICATION REDUCTION AND/OR REDUCED WASO), GUIDE THE DESIGN OF A PIVOTAL TRIAL FOR FDA CLEARANCE, AND INFORM THE CHOICE OF PATIENT POPULATIONS TO TARGET IN THE COMMERCIALIZATION STRATEGY.
$1.3m
5/19/26
Not listed
DEVELOPING CLOSED-LOOP TONIC MOTOR ACTIVATION THERAPY FOR TREATMENT OF REFRACTORY RESTLESS LEGS SYNDROME - SUMMARY: RESTLESS LEGS SYNDROME (RLS) IS A PREVALENT AND DEBILITATING SLEEP DISORDER THAT AFFECTS A SIGNIFICANT PORTION OF THE ADULT POPULATION, LEADING TO CONSIDERABLE SLEEP DEPRIVATION AND A REDUCTION IN QUALITY OF LIFE. CURRENT TREATMENTS FOR RLS PROVIDE MIXED RESULTS AND, IN THE CASE OF MEDICATIONS, UNDESIRABLE SIDE EFFECTS. THE NEED FOR INNOVATIVE SOLUTIONS IS CLEAR. THE NOCTRIX TONIC MOTOR ACTIVATION SYSTEM (TOMAC) REPRESENTS A NOVEL APPROACH TO RLS MANAGEMENT THROUGH NON-INVASIVE PERIPHERAL NERVE STIMULATION, OFFERING A PROMISING ALTERNATIVE TO TRADI- TIONAL THERAPIES. DESPITE THE SUCCESS OF TOMAC 1.0 IN REDUCING RLS SYMPTOMS, CHALLENGES REMAIN IN REDUCING SLEEP FRAGMENTATION AND FACILITATING MEDICATION REDUCTION. THE PROPOSED SBIR PHASE IIB PROJECT AIMS TO DEVELOP AND CLINICALLY VALIDATE A CLOSED-LOOP VERSION OF TOMAC (CL-TOMAC) TO ADDRESS THESE UNMET NEEDS. CL-TOMAC WILL USE LEG MOVEMENT DETECTION ALGORITHMS DEVELOPED IN THE PRIOR SBIR PHASE II TO AUTOMATICALLY ACTIVATE THERAPY DURING SLEEP TO REDUCE WAKE AFTER SLEEP ONSET (WASO). ADDITIONALLY, CL-TOMAC WILL FACILITATE REDUCTION IN THE DOSAGE OF COMMON RLS MEDICATIONS (DOPAMINERGICS AND OPIOIDS), ALLEVIATING THE SIDE EFFECTS ASSOCIATED WITH LONG-TERM MEDICATION USE. THE PROJECT IS STRUCTURED AROUND THREE SPECIFIC AIMS: 1) DEVELOP AND VERIFY A CLOSED- LOOP STIMULATION ALGORITHM THAT IS SENSITIVE AND SPECIFIC IN DETECTING THE NEED FOR ACTIVATION DURING SLEEP, 2) ASSESS THE FEASIBILITY OF CL-TOMAC IN REDUCING WASO IN PATIENTS WITH REFRACTORY RLS, AND 3) EVALUATE THE POTENTIAL OF CL-TOMAC TO FACILITATE REDUCTIONS IN COMMON RLS MEDICATION DOSAGES. SUCCESS WILL BE MEASURED THROUGH RIGOROUS CLINICAL AND TECHNICAL VALIDATION PROCESSES, INCLUDING POLYSOMNOGRAPHY, ACTIGRAPHY, AND MEDICATION DOS- AGE ASSESSMENTS. BY ADDRESSING THESE CRITICAL CHALLENGES, CL-TOMAC PROMISES TO IMPROVE HEALTH OUTCOMES AND ENHANCE QUALITY OF LIFE FOR THOSE AFFECTED BY RLS. FOLLOWING SUCCESSFUL COMPLETION, THE RESULTS OF AIMS 2-3 WILL DETERMINE THE INTENDED USE FOR CL-TOMAC (EXPANDED TO INCLUDE MEDICATION REDUCTION AND/OR REDUCED WASO), GUIDE THE DESIGN OF A PIVOTAL TRIAL FOR FDA CLEARANCE, AND INFORM THE CHOICE OF PATIENT POPULATIONS TO TARGET IN THE COMMERCIALIZATION STRATEGY.
$515.5k
5/12/25
Not listed
TREATMENT OF RESTLESS LEGS SYNDROME THROUGH NON-INVASIVE PERIPHERAL NERVE STIMULATION - RESTLESS LEGS SYNDROME (RLS) AFFECTS THE ABILITY TO FALL AND STAY ASLEEP FOR MORE THAN 10% OF THE WESTERN ADULT POPULATION. IN THE MEDIAN AGE GROUP OF 50-79 YEARS ALONE, MORE THAN 25 MILLION ADULTS ARE SEEKING TREATMENT FOR RLS, MAKING IT THE SECOND MOST COMMON SLEEP DISORDER IN THE WORLD. THE SEVERE LEG SENSATIONS OF RLS ARE MOST PREVALENT AT NIGHT, THUS LEADING TO SLEEP DEPRIVATION AND ITS DOWNSTREAM CONSEQUENCES OF DEPRESSED MOOD, IRRITABILITY, FORGETFULNESS, DIFFICULTY LEARNING, AND LACK OF MOTIVATION. VOLUNTARY LEG MOVEMENTS LEAD TO REDUCTION IN THESE SYMPTOMS; HOWEVER, SUCH MOVEMENTS ARE INCOMPATIBLE WITH SLEEP. DRUG-BASED RLS THERAPIES ARE MET WITH MIXED RESULTS, BECOMING PROGRESSIVELY LESS EFFECTIVE OVER TIME, AND IN MANY CASES HAVING DEBILITATING SIDE- EFFECTS. FOR THIS REASON, A SIGNIFICANT PORTION OF RLS PATIENTS MOVE TO OFF-LABEL MEDICATIONS, INCLUDING OPIATES AND BENZODIAZEPINES. THERE EXISTS A LARGE UNMET NEED FOR AN EFFECTIVE NON-DRUG RLS THERAPY. THE NOCTRIX HEALTH WEARABLE PERIPHERAL NERVE STIMULATION SYSTEM (NPNS) IS DESIGNED TO MIMIC THE THERAPEUTIC BENEFITS OF VOLUNTARY LEG MOVEMENTS WITHOUT THE DISTRACTING SIDE-EFFECTS. INITIAL OPEN-LABEL STUDIES OF ACUTE THERAPEUTIC RESPONSE SHOW THAT NPNS REDUCES RLS SYMPTOM SEVERITY BY 83% IN MODERATE TO SEVERE RLS PATIENTS. DEVICE DEVELOPMENT WORK IS REQUIRED TO TRANSLATE THE NPNS TECHNOLOGY INTO A COMPACT, WEARABLE DEVICE THAT CAN BE RELIABLY SELF- ADMINISTERED BY PATIENTS IN THE HOME FOR DAILY OVERNIGHT USE. CLINICAL VALIDATION IS REQUIRED TO DETERMINE PRELIMINARY THERAPEUTIC RESPONSE IN KEY PATIENT SUB-POPULATIONS. THIS SBIR FAST TRACK PROPOSAL WILL FACILITATE THE TRANSLATION OF THIS PROMISING TECHNOLOGY INTO A WEARABLE, SIMPLE-TO-USE DEVICE AND EVALUATE TOLERABILITY, SAFETY, COMPLIANCE, AND RESPONSE TO TREATMENT FOR CANDIDATE CLINICAL SUB-POPULATIONS (DRUG-NAIVE, DRUG- REFRACTORY, AND CLINICIAN-GUIDED OPIATE-REDUCTION) THROUGH THE FOLLOWING AIMS: PHASE I AIM 1: DESIGN AND VALIDATE FORM FACTOR MOST COMPATIBLE FOR DAILY OVERNIGHT USE. DESIGN A WEARABLE DEVICE THAT CAN DELIVER THE PROGRAMMED THERAPY WAVEFORM UNINTERRUPTED FOR THE REQUISITE DURATION WITH A FORM FACTOR THAT IS MINIMALLY DISRUPTIVE TO SLEEP FROM EXISTING COMPANY-SOURCED PATIENT AND PHYSICIAN FEEDBACK. AIM 2: INTEGRATE COMPLIANCE TRACKING AND ACTIVITY MONITORING. DESIGN AND INTEGRATE 3D MOTION SMART SENSING AND EVENT LOGGING INTO THE DEVICE. PHASE 2 AIM 1: ESTABLISH TOLERABILITY, COMPLIANCE, SAFETY, AND IDENTIFY CLINICAL SUB- POPULATION THERAPEUTIC RESPONSE. CONDUCT A CLINICAL TRIAL WITH 20 PATIENTS IN EACH OF 3 COHORTS (DRUG-NAIVE, DRUG-REFRACTORY, AND CLINICIAN-GUIDED OPIATE-REDUCTION) TO STUDY TOLERABILITY, SAFETY, COMPLIANCE, AND SIZE OF TREATMENT EFFECT. AIM 2: DEVELOP ALGORITHM FOR DETECTION OF RLS-RELATED LEG MOVEMENTS. USING THE DATA PROVIDED BY ON-BOARD SENSORS (DEVELOPED IN PHASE 1 AND COLLECTED IN PHASE II AIM 1), DEVELOP AN ALGORITHM FOR DETECTION OF RLS-RELATED LEG MOVEMENTS DURING SLEEP. THE ALGORITHM WILL REPORT AN OBJECTIVE STATE MARKER OF SYMPTOM SEVERITY AND WILL ULTIMATELY BE USED TO APPLY PULSES TO MAINTAIN SLEEP, WHEN NECESSARY. SUCCESSFUL COMPLETION OF THIS CLINICAL TRIAL WILL SUPPORT ADVANCEMENT TO AN NPNS PIVOTAL TRIAL AND FDA APPROVAL.
$0
7/22/24
Not listed
TREATMENT OF RESTLESS LEGS SYNDROME THROUGH NON-INVASIVE PERIPHERAL NERVE STIMULATION - RESTLESS LEGS SYNDROME (RLS) AFFECTS THE ABILITY TO FALL AND STAY ASLEEP FOR MORE THAN 10% OF THE WESTERN ADULT POPULATION. IN THE MEDIAN AGE GROUP OF 50-79 YEARS ALONE, MORE THAN 25 MILLION ADULTS ARE SEEKING TREATMENT FOR RLS, MAKING IT THE SECOND MOST COMMON SLEEP DISORDER IN THE WORLD. THE SEVERE LEG SENSATIONS OF RLS ARE MOST PREVALENT AT NIGHT, THUS LEADING TO SLEEP DEPRIVATION AND ITS DOWNSTREAM CONSEQUENCES OF DEPRESSED MOOD, IRRITABILITY, FORGETFULNESS, DIFFICULTY LEARNING, AND LACK OF MOTIVATION. VOLUNTARY LEG MOVEMENTS LEAD TO REDUCTION IN THESE SYMPTOMS; HOWEVER, SUCH MOVEMENTS ARE INCOMPATIBLE WITH SLEEP. DRUG-BASED RLS THERAPIES ARE MET WITH MIXED RESULTS, BECOMING PROGRESSIVELY LESS EFFECTIVE OVER TIME, AND IN MANY CASES HAVING DEBILITATING SIDE- EFFECTS. FOR THIS REASON, A SIGNIFICANT PORTION OF RLS PATIENTS MOVE TO OFF-LABEL MEDICATIONS, INCLUDING OPIATES AND BENZODIAZEPINES. THERE EXISTS A LARGE UNMET NEED FOR AN EFFECTIVE NON-DRUG RLS THERAPY. THE NOCTRIX HEALTH WEARABLE PERIPHERAL NERVE STIMULATION SYSTEM (NPNS) IS DESIGNED TO MIMIC THE THERAPEUTIC BENEFITS OF VOLUNTARY LEG MOVEMENTS WITHOUT THE DISTRACTING SIDE-EFFECTS. INITIAL OPEN-LABEL STUDIES OF ACUTE THERAPEUTIC RESPONSE SHOW THAT NPNS REDUCES RLS SYMPTOM SEVERITY BY 83% IN MODERATE TO SEVERE RLS PATIENTS. DEVICE DEVELOPMENT WORK IS REQUIRED TO TRANSLATE THE NPNS TECHNOLOGY INTO A COMPACT, WEARABLE DEVICE THAT CAN BE RELIABLY SELF- ADMINISTERED BY PATIENTS IN THE HOME FOR DAILY OVERNIGHT USE. CLINICAL VALIDATION IS REQUIRED TO DETERMINE PRELIMINARY THERAPEUTIC RESPONSE IN KEY PATIENT SUB-POPULATIONS. THIS SBIR FAST TRACK PROPOSAL WILL FACILITATE THE TRANSLATION OF THIS PROMISING TECHNOLOGY INTO A WEARABLE, SIMPLE-TO-USE DEVICE AND EVALUATE TOLERABILITY, SAFETY, COMPLIANCE, AND RESPONSE TO TREATMENT FOR CANDIDATE CLINICAL SUB-POPULATIONS (DRUG-NAIVE, DRUG- REFRACTORY, AND CLINICIAN-GUIDED OPIATE-REDUCTION) THROUGH THE FOLLOWING AIMS: PHASE I AIM 1: DESIGN AND VALIDATE FORM FACTOR MOST COMPATIBLE FOR DAILY OVERNIGHT USE. DESIGN A WEARABLE DEVICE THAT CAN DELIVER THE PROGRAMMED THERAPY WAVEFORM UNINTERRUPTED FOR THE REQUISITE DURATION WITH A FORM FACTOR THAT IS MINIMALLY DISRUPTIVE TO SLEEP FROM EXISTING COMPANY-SOURCED PATIENT AND PHYSICIAN FEEDBACK. AIM 2: INTEGRATE COMPLIANCE TRACKING AND ACTIVITY MONITORING. DESIGN AND INTEGRATE 3D MOTION SMART SENSING AND EVENT LOGGING INTO THE DEVICE. PHASE 2 AIM 1: ESTABLISH TOLERABILITY, COMPLIANCE, SAFETY, AND IDENTIFY CLINICAL SUB- POPULATION THERAPEUTIC RESPONSE. CONDUCT A CLINICAL TRIAL WITH 20 PATIENTS IN EACH OF 3 COHORTS (DRUG-NAIVE, DRUG-REFRACTORY, AND CLINICIAN-GUIDED OPIATE-REDUCTION) TO STUDY TOLERABILITY, SAFETY, COMPLIANCE, AND SIZE OF TREATMENT EFFECT. AIM 2: DEVELOP ALGORITHM FOR DETECTION OF RLS-RELATED LEG MOVEMENTS. USING THE DATA PROVIDED BY ON-BOARD SENSORS (DEVELOPED IN PHASE 1 AND COLLECTED IN PHASE II AIM 1), DEVELOP AN ALGORITHM FOR DETECTION OF RLS-RELATED LEG MOVEMENTS DURING SLEEP. THE ALGORITHM WILL REPORT AN OBJECTIVE STATE MARKER OF SYMPTOM SEVERITY AND WILL ULTIMATELY BE USED TO APPLY PULSES TO MAINTAIN SLEEP, WHEN NECESSARY. SUCCESSFUL COMPLETION OF THIS CLINICAL TRIAL WILL SUPPORT ADVANCEMENT TO AN NPNS PIVOTAL TRIAL AND FDA APPROVAL.
$0
7/22/24
Not listed
TREATMENT OF RESTLESS LEGS SYNDROME THROUGH NON-INVASIVE PERIPHERAL NERVE STIMULATION - RESTLESS LEGS SYNDROME (RLS) AFFECTS THE ABILITY TO FALL AND STAY ASLEEP FOR MORE THAN 10% OF THE WESTERN ADULT POPULATION. IN THE MEDIAN AGE GROUP OF 50-79 YEARS ALONE, MORE THAN 25 MILLION ADULTS ARE SEEKING TREATMENT FOR RLS, MAKING IT THE SECOND MOST COMMON SLEEP DISORDER IN THE WORLD. THE SEVERE LEG SENSATIONS OF RLS ARE MOST PREVALENT AT NIGHT, THUS LEADING TO SLEEP DEPRIVATION AND ITS DOWNSTREAM CONSEQUENCES OF DEPRESSED MOOD, IRRITABILITY, FORGETFULNESS, DIFFICULTY LEARNING, AND LACK OF MOTIVATION. VOLUNTARY LEG MOVEMENTS LEAD TO REDUCTION IN THESE SYMPTOMS; HOWEVER, SUCH MOVEMENTS ARE INCOMPATIBLE WITH SLEEP. DRUG-BASED RLS THERAPIES ARE MET WITH MIXED RESULTS, BECOMING PROGRESSIVELY LESS EFFECTIVE OVER TIME, AND IN MANY CASES HAVING DEBILITATING SIDE- EFFECTS. FOR THIS REASON, A SIGNIFICANT PORTION OF RLS PATIENTS MOVE TO OFF-LABEL MEDICATIONS, INCLUDING OPIATES AND BENZODIAZEPINES. THERE EXISTS A LARGE UNMET NEED FOR AN EFFECTIVE NON-DRUG RLS THERAPY. THE NOCTRIX HEALTH WEARABLE PERIPHERAL NERVE STIMULATION SYSTEM (NPNS) IS DESIGNED TO MIMIC THE THERAPEUTIC BENEFITS OF VOLUNTARY LEG MOVEMENTS WITHOUT THE DISTRACTING SIDE-EFFECTS. INITIAL OPEN-LABEL STUDIES OF ACUTE THERAPEUTIC RESPONSE SHOW THAT NPNS REDUCES RLS SYMPTOM SEVERITY BY 83% IN MODERATE TO SEVERE RLS PATIENTS. DEVICE DEVELOPMENT WORK IS REQUIRED TO TRANSLATE THE NPNS TECHNOLOGY INTO A COMPACT, WEARABLE DEVICE THAT CAN BE RELIABLY SELF- ADMINISTERED BY PATIENTS IN THE HOME FOR DAILY OVERNIGHT USE. CLINICAL VALIDATION IS REQUIRED TO DETERMINE PRELIMINARY THERAPEUTIC RESPONSE IN KEY PATIENT SUB-POPULATIONS. THIS SBIR FAST TRACK PROPOSAL WILL FACILITATE THE TRANSLATION OF THIS PROMISING TECHNOLOGY INTO A WEARABLE, SIMPLE-TO-USE DEVICE AND EVALUATE TOLERABILITY, SAFETY, COMPLIANCE, AND RESPONSE TO TREATMENT FOR CANDIDATE CLINICAL SUB-POPULATIONS (DRUG-NAIVE, DRUG- REFRACTORY, AND CLINICIAN-GUIDED OPIATE-REDUCTION) THROUGH THE FOLLOWING AIMS: PHASE I AIM 1: DESIGN AND VALIDATE FORM FACTOR MOST COMPATIBLE FOR DAILY OVERNIGHT USE. DESIGN A WEARABLE DEVICE THAT CAN DELIVER THE PROGRAMMED THERAPY WAVEFORM UNINTERRUPTED FOR THE REQUISITE DURATION WITH A FORM FACTOR THAT IS MINIMALLY DISRUPTIVE TO SLEEP FROM EXISTING COMPANY-SOURCED PATIENT AND PHYSICIAN FEEDBACK. AIM 2: INTEGRATE COMPLIANCE TRACKING AND ACTIVITY MONITORING. DESIGN AND INTEGRATE 3D MOTION SMART SENSING AND EVENT LOGGING INTO THE DEVICE. PHASE 2 AIM 1: ESTABLISH TOLERABILITY, COMPLIANCE, SAFETY, AND IDENTIFY CLINICAL SUB- POPULATION THERAPEUTIC RESPONSE. CONDUCT A CLINICAL TRIAL WITH 20 PATIENTS IN EACH OF 3 COHORTS (DRUG-NAIVE, DRUG-REFRACTORY, AND CLINICIAN-GUIDED OPIATE-REDUCTION) TO STUDY TOLERABILITY, SAFETY, COMPLIANCE, AND SIZE OF TREATMENT EFFECT. AIM 2: DEVELOP ALGORITHM FOR DETECTION OF RLS-RELATED LEG MOVEMENTS. USING THE DATA PROVIDED BY ON-BOARD SENSORS (DEVELOPED IN PHASE 1 AND COLLECTED IN PHASE II AIM 1), DEVELOP AN ALGORITHM FOR DETECTION OF RLS-RELATED LEG MOVEMENTS DURING SLEEP. THE ALGORITHM WILL REPORT AN OBJECTIVE STATE MARKER OF SYMPTOM SEVERITY AND WILL ULTIMATELY BE USED TO APPLY PULSES TO MAINTAIN SLEEP, WHEN NECESSARY. SUCCESSFUL COMPLETION OF THIS CLINICAL TRIAL WILL SUPPORT ADVANCEMENT TO AN NPNS PIVOTAL TRIAL AND FDA APPROVAL.
$0
8/22/21