Clinical trials: Brain Stimulation
Sensorimotor Gait Disorder, Neurologic Ambulation Disorder
Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop
The objective of this study is to determine the effectiveness of the NESS L300 (L300) in improving gait parameters, function, and quality of life among stroke subjects (greater than or equal to 3 months post stroke)with drop foot.
- Conditions
- Sensorimotor Gait Disorder, Neurologic Ambulation Disorder, Gait, Drop Foot, Poststroke Hemiparesis
- Trial name
- L300 (NCT01138995)
- Testing
- Ness L300, Ankle-foot orthosis
- Where
- 11 sites in United States
- Volunteers
- 197 people
- Sponsor
- Bioness Inc
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
Epilepsy
RNS® System Pivotal Study
The RNS® System Pivotal study is designed to assess safety and demonstrate that the RNS® System is effective as an adjunctive (add-on) therapy in reducing the frequency of seizures in individuals 18 years of age or older with…
- Trial name
- NCT00264810
- Testing
- RNS® System implantation, RNS® System responsive stimulation
- Where
- 32 sites in United States
- Volunteers
- 240 people
- Sponsor
- NeuroPace
Parkinson Disease
Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action Tremor
Demonstrate safety and efficacy of TAPS delivered by a Cala device as a treatment for action tremor in subjects with Parkinson's disease hand tremor
- Trial name
- NCT05012579
- Testing
- Cala Device
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Cala Health, Inc.
Cluster Headache
A Randomized Multicentre Study for the Acute Relief of Episodic and Chronic Cluster Headache.
The study will look at a non-invasive treatment for people suffering with chronic and episodic headaches. Study subjects will be randomized to an active treatment or an in-active treatment for 2 weeks.
- Trial name
- NCT01958125
- Testing
- gammaCore
- Where
- 9 sites in Denmark, Germany and 2 more
- Volunteers
- 102 people
- Sponsor
- ElectroCore INC
Cerebrovascular Stroke, Upper Extremity Paresis
Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB)
This is a pivotal phase study of up to 120 subjects and 15 clinical sites. All subjects are implanted with the Vivistim System® and then randomized to either study treatment or active-control treatment.
- Trial name
- VNS-REHAB (NCT03131960)
- Testing
- Paired Vagus Nerve Stimulation, Rehabilitation
- Where
- 20 sites in United States, United Kingdom
- Volunteers
- 108 people
- Sponsor
- MicroTransponder Inc.
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
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
Cluster Headache
Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache
Multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of cluster headache.
- Trial name
- CH (NCT01792817)
- Testing
- GammaCore
- Where
- 20 sites in United States
- Volunteers
- 150 people
- Sponsor
- ElectroCore INC
Migraine
RCT of Non-Invasive Vagus Nerve Stimulation (nVNS) With gammaCore®, for the Acute Treatment of Migraine Attacks
This study is a prospective, multi-centre, randomised, double-blind, sham-controlled investigation designed for comparison of two parallel treatment groups: gammaCore (active nVNS treatment) and a Sham device (control treatment)…
- Trial name
- NCT02686034
- Testing
- gammaCore-S
- Where
- 10 sites in Italy
- Volunteers
- 285 people
- Sponsor
- ElectroCore INC
Migraine
Treatment for Migraines With an Implantable Device
The purpose of this study is to evaluate the safety and effectiveness of an implantable device for difficult to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative…
- Trial name
- NCT00286078
- Testing
- Precision
- Where
- 15 sites in United States
- Volunteers
- 179 people
- Sponsor
- Boston Scientific Corporation
Parkinson's Disease
CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation
The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system.
- Trial name
- CUSTOM-DBS (NCT01896115)
- Testing
- Vercise DBS settings
- Where
- 10 sites in United States, Austria and 3 more
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Epilepsy
RNS® System Feasibility Study
The RNS® System is intended to treat patients with medically refractory (hard to treat) epilepsy. The RNS® System Feasibility study is designed to demonstrate safety and evidence of effectiveness of the RNS® System to support the…
- Trial name
- NCT00079781
- Testing
- RNS® System implantation, RNS® System responsive stimulation
- Where
- 12 sites in United States
- Volunteers
- 70 people
- Sponsor
- NeuroPace
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
Stroke
Mobility Training Using a Bionic Knee Orthosis in Patients Chronic Post-Stroke: A Case Series
This pilot study examined the effect of task-oriented mobility training in three persons chronic post-stroke using a novel, wearable, mobile intention-based robotic orthosis (Tibion Bionic Leg).
- Trial name
- NCT01499862
- Testing
- Tibion Bionic Leg
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Tibion Bionics, 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
Epilepsy
RNS® System LTT Study
The RNS® System LTT study is designed to assess the ongoing safety and to evaluate the long-term efficacy of the RNS® System as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older…
- Trial name
- NCT00572195
- Testing
- RNS® System
- Where
- 33 sites in United States
- Volunteers
- 230 people
- Sponsor
- NeuroPace
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
Epilepsy
SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
The purpose of this research is to study the safety and effectiveness of bilateral stimulation of the anterior nucleus of the thalamus as adjunctive therapy for reducing the frequency of seizures in adults diagnosed with epilepsy…
- Trial name
- NCT00101933
- Testing
- Medtronic DBS Therapy for epilepsy
- Volunteers
- 157 people
- Sponsor
- MedtronicNeuro