Clinical trials: DBS
Parkinson's Disease
Deep Brain Stimulation Effects Study
The purpose of this study is to provide proof-of-concept that the test product can perform as intended in an intra-operative setting and the responses to the test product are perceivable in a person.
- Trial name
- NCT01098565
- Testing
- Study device HFR0001
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- MedtronicNeuro
Parkinson's Disease (PD)
Coordinated Reset Deep Brain Stimulation
The study will explore the viability of an alternative/novel programming strategy in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).
- Trial name
- RESET-DBS (NCT03732898)
- Testing
- Novel Programming (nDBS), Conventional Programming (cDBS)
- Where
- 2 sites in Germany
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Idiopathic Parkinson's Disease
Vercise Implantable Stimulator for Treating Parkinson's Disease
The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of…
- Trial name
- VANTAGE (NCT01221948)
- Testing
- Deep Brain Stimulation
- Where
- 7 sites in Austria, France and 4 more
- Volunteers
- 53 people
- Sponsor
- Boston Scientific Corporation
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
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
LFP Beta aDBS Feasibility Study
The purpose of this study is to use local field potentials as control signals for adjusting DBS stimulation settings under varying patient states and to assess patient outcomes.
- Trial name
- NCT03446833
- Testing
- The LFP Beta aDBS System
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- MedtronicNeuro
Parkinson's Disease (PD)
Phase I Clinical Study of NouvNeu001 Injection for the Treatment of Moderate-to-Advanced Parkinson's Disease in Patients Who Have Previously Undergone Deep Brain Stimulation or Deep Brain Nucleus Lesioning Surgery
This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's Disease who have…
- Trial name
- NCT07550374
- Testing
- NouvNeu001 injection
- Where
- China
- Volunteers
- 10 people
- Sponsor
- iRegene Therapeutics Co., Ltd.
Parkinson's Disease
Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's…
- Trial name
- INTREPID (NCT01839396)
- Testing
- Deep Brain Stimulation
- Where
- 22 sites in United States
- Volunteers
- 313 people
- Sponsor
- Boston Scientific Corporation
Abdominal Pain, Functional Abdominal Pain
Epidemiological Analysis for Hereditary Angioedema Disease
An international, multicenter, epidemiological, observational study investigating the prevalence of Hereditary Angioedema (HAE) disease among participants with recurrent episodes of abdominal pain of no obvious etiology.
- Trial name
- EHA (NCT03558009)
- Where
- 35 sites in Germany, Italy and 4 more
- Volunteers
- 2,318 people
- Sponsor
- CENTOGENE GmbH Rostock
Obesity
PINS Stimulator System for Deep Brain Stimulation to Treat Obesity
The purpose of this clinical study is to verify the long term effecacy and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with obesity.
- Trial name
- NCT02254395
- Testing
- Deep Brain Stimulation
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Beijing Pins Medical Co., Ltd
Stroke, Upper Extremity Paresis
Pilot/Pivotal Study of DBS+Rehab After Stroke
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
- Trial name
- RESTORE (NCT05701280)
- Testing
- Deep Brain Stimulation, Rehabilitation
- Where
- 9 sites in United States
- Volunteers
- 202 people
- Sponsor
- Enspire DBS Therapy, Inc.
Parkinson Disease
Cartesia eXTend 3D Study
The purpose of the study is to document patient outcomes including effectiveness for Boston Scientific Corporation's Vercise Cartesia 16-contact Directional Lead(s) (X/HX) with Deep Brain Stimulation (DBS) systems for the…
- Trial name
- eXTend 3D (NCT04577651)
- Testing
- 16-contact Directional Deep Brain Stimulation
- Where
- 10 sites in Germany, Netherlands and 1 more
- Volunteers
- 58 people
- Sponsor
- Boston Scientific Corporation
Tremor, Action Tremor
Deep Brain Stimulation (DBS) for the Suppression of Tremor
The purpose of the proposed study is to demonstrate the safety and efficacy of the ANS Totally Implantable Deep Brain Stimulation System in the VIM nucleus of the thalamus implanted for the treatment of tremor due to essential…
- Conditions
- Tremor, Action Tremor, Essential Tremor, Tremor, Limb
- Trial name
- NCT02087046
- Testing
- ANS Totally Implantable Deep Brain Stimulation System
- Where
- 12 sites in United States
- Volunteers
- 127 people
- Sponsor
- Abbott Medical Devices
Dystonia
Vercise™ DBS Dystonia Prospective Study
To compile characteristics of real-world outcomes of Boston Scientific Corporation's commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of dystonia.
- Trial name
- NCT02686125
- Testing
- Deep Brain Stimulation (DBS)
- Where
- 36 sites in Belgium, Canada and 10 more
- Volunteers
- 300 people
- Sponsor
- Boston Scientific Corporation
Parkinson Disease, Essential Tremor
Deep Brain Stimulation (DBS) Retrospective Outcomes Study
The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.
- Conditions
- Parkinson Disease, Essential Tremor, Dystonia
- Trial name
- NCT03664609
- Testing
- Deep Brain Stimulation
- Where
- 20 sites in United States, Belgium and 4 more
- Volunteers
- 5,000 people
- Sponsor
- Boston Scientific Corporation
Parkinson's Disease, Essential Tremor
Evaluation of Directional Recording and Stimulation Using spiderSTN
The purpose of this study is to provide proof-of-concept that directional stimulation and directional recording, in an intraoperative setting, is perceivable in a subject.
- Trial name
- NCT02894567
- Testing
- Intraoperative test during a deep brain stimulation surgery
- Where
- Switzerland
- Volunteers
- 6 people
- Sponsor
- Aleva Neurotherapeutics SA
Parkinson's Disease
Satisfaction Survey on PINS Stimulator System for Patients With Parkinson's Disease
This study will be done because the investigators would like to evaluate product satisfaction of two PINS products (product A, product B) that are to evaluate the effectiveness of rechargeable and non-rechargeable Deep Brain…
- Trial name
- NCT02251808
- Where
- China
- Volunteers
- 612 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Epilepsy
Brain Stimulation for Epilepsy Long Term Follow-up
The purpose of this study is to collect subject data to evaluate the rate of sudden unexplained death in epilepsy (SUDEP) with bilateral neurostimulation of the anterior nucleus of the thalamus in people diagnosed with refractory…
- Trial name
- SUDEP (NCT00736424)
- Testing
- Itrel II™ and Soletra™ Epilepsy Control System
- Volunteers
- 9 people
- Sponsor
- MedtronicNeuro
Essential Tremor
Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)
To compile characteristics of real-world outcomes for Boston Scientific Corporation's commercially approved Deep Brain Stimulation (DBS) Systems, when used according to the applicable Directions for Use, for the treatment of…
- Trial name
- NCT04032470
- Testing
- Deep Brain Stimulation Systems (DBS)
- Where
- 20 sites in Austria, Belgium and 7 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Validation, Dried Blood Spot
To Validate an Analytical Method to Measure Concentration of Tacrolimus in Blood Taken From Finger Pricks
The principal aim of this study is to define the relationship between tacrolimus concentrations determined from the finger prick DBS (Dry Blood Spot) method and those determined from blood samples collected by venepuncture in…
- Conditions
- Validation, Dried Blood Spot, Transplant Patients
- Trial name
- NCT02377609
- Testing
- Tacrolimus
- Where
- 6 sites in France, United Kingdom
- Volunteers
- 108 people
- Sponsor
- Astellas Pharma Europe Ltd.