Clinical trials: Closed-Loop
Parkinson Disease(PD)
Adaptive DBS for PD
The goal of this clinical trial is to evaluate the efficacy and safety of an adaptive deep brain stimulation (aDBS) system for managing Parkinson's disease symptoms.
- Trial name
- SMART-DBS (NCT07635823)
- Testing
- adaptive deep brain stimulation, conventional deep brain stimulation
- Where
- 9 sites in China
- Volunteers
- 60 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Heart Failure, Cognitive Impairment
HeartMapp: Assessment and Treatment for Heart Failure
In the current application, the investigators propose to elaborate upon, reconstruct and advance to pivotal trial readiness a recently validated mobile application (HeartMapp), designed for the ecological momentary assessment and…
- Trial name
- HeartMapp (NCT03827954)
- Testing
- HeartMapp+CT
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Posit Science Corporation
Diabetes Mellitus, Type 2
Closed Loop Glucose Control in Patients With Type 2 Diabetes
This is a proof of concept safety study of an artificial intelligence based closed loop glucose control system designed for use in the intensive care unit setting.
- Trial name
- NCT05386849
- Testing
- FUSION closed loop glucose control system
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ideal Medical Technologies
Type 1 Diabetes
Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes
The main objective is to determine the efficacy of Lyumjev (insulin) in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1.
- Trial name
- FAST 1 (NCT05508061)
- Testing
- Insulin Lispro Cartridge [Lyumjev], Insulin Lispro Cartridge
- Where
- 3 sites in Netherlands
- Volunteers
- 12 people
- Sponsor
- Inreda Diabetic B.V.
Depression - Major Depressive Disorder, Transcranial Alternating Current Stimulation
Individualized Non-invasive Brain Stimulation for the Treatment of Major Depressive Disorder
The purpose of this research study is to study a closed-loop transcranial alternating current stimulation (tACS) device to evaluate feasibility of the product in a clinical trial and collect preliminary data on potential effects…
- Trial name
- CL-tACS RCT (NCT06874374)
- Testing
- Closed-loop tACS
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Pulvinar Neuro, LLC
Post-Concussion Symptoms, Insomnia
Neurotechnology Following Traumatic Brain Injury
This two-part study seeks to improve symptoms such as pain and sleep problems after concussion, or mild traumatic brain injury (mTBI).
- Conditions
- Post-Concussion Symptoms, Insomnia, Pain, Chronic, Depressive Symptoms
- Trial name
- Cereset (NCT03649958)
- Testing
- HIRREM-SOP or Cereset, Cereset 2x
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Brain State Technologies, LLC
Diabetic Peripheral Neuropathic Pain (DPN)
Medtronic Inceptiv™ Closed-Loop DTM Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy
This study is conducted to evaluate a new way of using spinal cord stimulation (SCS) in people with painful diabetic peripheral neuropathy (DPN).
- Trial name
- MED DPN (NCT07209514)
- Testing
- Implantable SCS with Closed Loop mechanism
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- TriCity Research Center
Type 1 Diabetes Mellitus
Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia
The purpose of the study is to compare the glycemic control during and following aerobic exercise using either an open or closed-loop insulin delivery system.
- Trial name
- ePID-03 (NCT00831389)
- Testing
- Closed Loop
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Medtronic MiniMed, Inc.
Type 1 Diabetes
Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes
This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in subjects with type 1 diabetes on insulin pump therapy.
- Trial name
- NCT02463097
- Testing
- Insulin Pump
- Where
- 10 sites in United States, Israel
- Volunteers
- 124 people
- Sponsor
- Medtronic MiniMed, Inc.
Bradycardia
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate…
- Trial name
- CLEAR (NCT00355797)
- Testing
- Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology, Non-rate adaptive (DDD) pacing
- Where
- 99 sites in United States
- Volunteers
- 1,491 people
- Sponsor
- Biotronik, Inc.
Small Fiber Neuropathy
Pilot Study to Evaluate Changes in Intra-Epidermal Nerve Fiber Density (IENFD) in Patients With Small-Fiber Neuropathy
This prospective observational pilot study will evaluate structural, functional, and patient-reported outcomes in adults with small fiber neuropathy who receive Saluda Evoke ECAP-controlled spinal cord stimulation as part of…
- Trial name
- SAL SFN PILOT (NCT07704931)
- Testing
- Evoke SCS system
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- TriCity Research Center
Diabetes Type 1
Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France
This is a non-interventional, longitudinal, prospective, multicenter, post market-registration and national study conducted in France.
- Trial name
- EPICAM-G6 (NCT07048795)
- Testing
- No Intervention: Observational Cohort
- Where
- 22 sites in France
- Volunteers
- 125 people
- Sponsor
- mylife Diabetes Care AG
Type 1 Diabetes
ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes
The purpose of this study evaluate the safety and efficacy of the Advanced Hybrid Closed Loop (AHCL) system in sub-optimally controlled patients with T1D, in comparison with Multiple Daily Injection (MDI) therapy with Flash…
- Trial name
- ADAPT (NCT04235504)
- Testing
- MDI, AHCL
- Where
- 14 sites in France, Germany and 1 more
- Volunteers
- 122 people
- Sponsor
- Medtronic MiniMed, Inc.
Sinus Node Disease
Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease
The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence…
- Trial name
- B3 (NCT02579889)
- Testing
- DDD+CLS, DDD(R)
- Where
- 54 sites in China, Hungary and 7 more
- Volunteers
- 1,390 people
- Sponsor
- Biotronik SE & Co. KG
Type 1 Diabetes
Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes
This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric subjects with type 1 diabetes on insulin pump therapy.
- Trial name
- NCT02660827
- Testing
- Insulin Pump
- Where
- 11 sites in United States, Israel
- Volunteers
- 151 people
- Sponsor
- Medtronic MiniMed, Inc.
Social Anxiety
Wiring Adolescents With Social Anxiety Via Behavioral Interventions
This study is a validation study to evaluate the acceptability, feasibility and impact of WASABI (Wiring Adolescents With Social Anxiety via Behavioral Interventions), a mobile application employing a closed-loop technology in…
- Trial name
- WASABI (NCT03990870)
- Testing
- dCBGT + WASABI, dCBGT Only
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Posit Science Corporation
Quality of Life, Burden, Dependency
Impact of the Use of a Closed-loop Insulin Therapy on the Burden of the Diabetes and the Quality of Life
The use by diabetes patients of real-time Continuous Glucose Monitoring (CGM) system is becoming widespread and has changed diabetic practice. Automated closed-loop (CL) insulin therapy has come of age.
- Trial name
- IMPLIQUE (NCT04939766)
- Testing
- Activation of a closed loop device in an insulin pump device with GCM
- Volunteers
- 250 people
- Sponsor
- VitalAire
Type 1 Diabetes
Overnight Closed Loop Study in U.S.
This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of…
- Trial name
- OCL (NCT01857973)
- Testing
- Hybrid Closed Loop
- Where
- 6 sites in United States
- Volunteers
- 78 people
- Sponsor
- Medtronic MiniMed, Inc.
Type 1 Diabetes
Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes
Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1 diabetes to evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin…
- Trial name
- NCT05403502
- Testing
- t:slim X2 insulin pump with Control-IQ technology 1.5
- Where
- 13 sites in United States
- Volunteers
- 183 people
- Sponsor
- Tandem Diabetes Care, Inc.
Hyperglycemia, Diabetes
Insulin Balanced Infusion System
The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without…
- Trial name
- NCT01291719
- Testing
- glucose and insulin infusions
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Admetsys Corporation