Clinical trials: Deep Brain Stimulation
Movement Disorders, Parkinson Disease
A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study.
- Conditions
- Movement Disorders, Parkinson Disease, Essential Tremor, Tremor
- Trial name
- NCT03884231
- Testing
- Infinity DBS System with MR Conditional labelling
- Where
- 16 sites in United States, France and 3 more
- Volunteers
- 74 people
- Sponsor
- Abbott Medical Devices
Treatment Resistant Depressive Disorder
Efficacy and Safety of DBS in Patients With Treatment-Resistant Depression
The habenula (Hb) is an ancient structure, located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions.
- Trial name
- NCT03667872
- Testing
- Bilateral implantation of DBS system to Habeluna
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Alzheimer Disease
ADvance DBS-f in Patients With Mild Probable Alzheimer's Disease
The primary objective of this feasibility study is to evaluate the safety of DBS-f in patients with mild Alzheimer's disease by assessing all device and/or therapy related adverse events.
- Trial name
- ADvance (NCT01608061)
- Testing
- DBS-f on, DBS-f off
- Where
- 7 sites in United States, Canada
- Volunteers
- 42 people
- Sponsor
- Functional Neuromodulation Ltd
Parkinson Disease
Safety and Efficacy of Adaptive Deep Brain Stimulation
The aim of this study is to assess the safety and the potential efficacy of personalized Local Field Potential (LFP)-based adaptive Deep Brain Stimulation (aDBS), using the implantable pulse generator (IPG) of the "AlphaDBS"…
- Trial name
- NCT04681534
- Testing
- AlphaDBS System
- Where
- 8 sites in Italy, Netherlands and 1 more
- Volunteers
- 15 people
- Sponsor
- Newronika
Chronic Traumatic Brain Injury, TBI (Traumatic Brain Injury)
Cognitive Network Restoration Therapy for Moderate to Severe Traumatic Brain Injury: A Feasibility Study
The purpose of this feasibility clinical investigation is to evaluate the safety and usability of central thalamic deep brain stimulation (CT-DBS) for use in patients with chronic moderate to severe traumatic brain injury (TBI)…
- Trial name
- NCT07730099
- Testing
- Deep brain stimulation
- Volunteers
- 40 people
- Sponsor
- ReEmerge, Inc.
PARKINSON DISEASE (Disorder), Cell Therapy
A Phase 1 Study of NCR201 in Parkinson's Disease Patients With Prior DBS
This is a Phase 1 clinical trial to evaluate the safety and tolerability of a new cell therapy called NCR201. The study will enroll adults with moderate-to-advanced primary Parkinson's disease who have previously undergone deep…
- Conditions
- PARKINSON DISEASE (Disorder), Cell Therapy, Human Induced Pluripotent Stem Cells, Deep Brain Stimulation
- Trial name
- NCR201-2004 (NCT07896187)
- Testing
- NCR201
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Nuwacell Biotechnologies Co., Ltd.
Refractory Epilepsy
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy
Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy.
- Trial name
- ANT-DBS-RE (NCT02602899)
- Testing
- PINS'Deep Brain Stimulator device
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Parkinson Disease, Gait Disorders, Neurologic
Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBS
The objective is to investigate whether AMPS (Automated Mechanical Peripheral Stimulation) is effective in reduction of FOG measured via the FOG-AC (Freezing Of Gait Assessment Course) in people with Parkinson Disease and STN-DBS…
- Trial name
- AMBITION (NCT04831879)
- Testing
- GONDOLA AMPS
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Gondola Medical Technologies SA
Parkinson's Disease, Essential Tremor
RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)
The purpose of this study is to assess the recharge feature of the Activa RC System in patients who are receiving Deep Brain Stimulation (DBS) for Parkinson's Disease (PD), Essential Tremor (ET), or dystonia.
- Conditions
- Parkinson's Disease, Essential Tremor, Dystonia
- Trial name
- RECHARGE (NCT00998660)
- Testing
- Activa RC
- Where
- 11 sites in United States, Austria and 4 more
- Volunteers
- 100 people
- Sponsor
- MedtronicNeuro
Treatment Resistant Depression, Depressive Disorder
A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression
This is a randomized, placebo-controlled double-blind cross-over trial evaluating the safety, efficacy, daily functioning, and health-related quality of life of Subcallosal Cingulate Gyrus Deep Brain Stimulation (SCG DBS) for…
- Trial name
- NCT01801319
- Testing
- Libra Deep Brain Stimulation System
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Abbott Medical Devices
Deep Brain Stimulation
SIS Evaluation of the MRI Defined Subthalamic Nucleus*
Retrospective review of images used to target the STN during DBS procedure and ability of the Surgical Information Sciences ("SIS") system to visualize the STN location.
- Trial name
- STN (NCT03907319)
- Testing
- SIS System
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Surgical Information Sciences Inc.
Depression
Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression
Medtronic, Inc. sponsored an investigational study of the Reclaim™ Deep Brain Stimulation (DBS) System in people that have treatment-resistant depression.
- Trial name
- NCT00837486
- Testing
- Reclaim™ DBS System
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- MedtronicNeuro
Huntington's Disease
PINS Stimulator System for Deep Brain Stimulation in Huntington's Disease
Deep Brain Stimulation (DBS) of the Globus pallidus internus(GPi) is useful in the treatment of different forms of chorea, including Huntington's disease (HD).
- Trial name
- NCT02263430
- Testing
- Deep Brain Stimulation
- Volunteers
- 8 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Refractory Epilepsy
Product Surveillance Registry- Deep Brain Stimulation for Epilepsy
The purpose of this observational registry is to evaluate the long-term effectiveness, safety and performance of market-released Medtronic Neuromodulation products for Deep Brain Stimulation (DBS) for the treatment of refractory…
- Trial name
- MORE (NCT01521754)
- Where
- 27 sites in Austria, Belgium and 11 more
- Volunteers
- 191 people
- Sponsor
- MedtronicNeuro
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
Parkinson Disease
Study on the Efficacy and Safety of Rechargeable Implantable DBS System in the Treatment of Parkinson's Disease
The purpose of this clinical trial is to verify the efficacy and safety of rechargeable implantable deep brain stimulation (DBS) system for the treatment of advanced primary Parkinson's disease.
- Trial name
- NCT05997667
- Testing
- Rechargeable implantable deep brain stimulation system
- Where
- 7 sites in China
- Volunteers
- 60 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Parkinson's Disease
Feasibility Study to Evaluate Deep Brain Stimulation (DBS) Settings for the Treatment of Parkinson's Disease
The purpose of this study is to assess the cognitive performance in patients with advanced Parkinson's disease receiving Deep Brain Stimulation (DBS) with settings predetermined clinically to settings derived from a…
- Trial name
- SAGE (NCT01230151)
- Testing
- GUIDE software, Version 0.1, Clinically defined stimulation parameters
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- Intelect Medical, Inc.
Parkinson Disease
Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
This study will test newly developed stimulation settings called Temporally Optimized Patterned Stimulation or TOPS, which can be used with an already implanted deep brain stimulation system.
- Trial name
- TOPS (NCT04390867)
- Testing
- TOPS1 DBS, TOPS2 DBS, TOPS3 DBS
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Deep Brain Innovations LLC
Parkinson Disease
Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
The purpose of the ROAM-DBS study is to compare the time needed to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the ADROIT initial programming visit in…
- Trial name
- ROAM-DBS (NCT05269862)
- Testing
- Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature, Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)
- Where
- 18 sites in United States, Germany and 2 more
- Volunteers
- 100 people
- Sponsor
- Abbott Medical Devices
Essential Tremor, Parkinson's Disease
Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool
The objective of this clinical investigation is to characterize the clinical performance of Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming InfinityTM deep brain stimulation (DBS)…
- Trial name
- EVIDENT (NCT03794661)
- Testing
- Clinician programmer electrode screening mode tool
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Abbott Medical Devices