Stroke, Ischemic Clinical Trial
Official title:
Feasibility of Trigeminal and Vagus Nerve Stimulation in Subjects With Chronic Upper Extremity Deficits After Stroke
This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study.
This pilot study will proceed in two phases: Phase I, an unblinded blinded stage and Phase II, a blinded stage comparing intervention and sham groups. Phase I will consist of 5 subjects, unblinded, receiving nTVNS. This phase will test the usability of the device and de-risk the use of nTVNS during rehabilitation. Visits will include consent and baseline evaluation followed by 6 weeks of treatment consisting of the standard of care with nTVNS. Rehabilitation and treatment will occur at a cadence of 3 sessions per week. Primary endpoints will be collected after 6 weeks. Phase II will consist of a Prospective Randomized Open, Blinded Endpoint (PROBE) design. Subjects will be randomized to an intervention nTVNS group or a control sham stimulation group. The control sham stimulation consists of standard-of-care rehabilitation with only a minimal amount of nTVNS delivered at the start of each session during a tolerability assessment intended to support further blinding for therapists and subjects. The same evaluations, sessions, and endpoints will occur as those in Phase I. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03993236 -
Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic Stroke
|
Phase 4 | |
| Completed |
NCT04069767 -
Innovative Physiotherapy in Stroke Rehabilitation
|
N/A | |
| Recruiting |
NCT06342206 -
The Assessment of Acute /Chronic Phase in Patients With Ischemic Cerebral Stroke Using TCM Diagnostic Tools
|
||
| Recruiting |
NCT03605381 -
MORbidity PRevalence Estimate In StrokE
|
||
| Enrolling by invitation |
NCT04956211 -
Periodontal Treatment and Ischemic Stroke
|
N/A | |
| Active, not recruiting |
NCT05098236 -
Effect of Visual Retraining on Visual Loss Following Visual Cortical Damage
|
N/A | |
| Completed |
NCT03942588 -
High-intensity Interval Training After Stroke
|
N/A | |
| Recruiting |
NCT04949334 -
Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke
|
N/A | |
| Terminated |
NCT04095767 -
Assessing Safety and Performance of the ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke
|
N/A | |
| Not yet recruiting |
NCT06352086 -
Understanding Visual Processing After Occipital Stroke
|
||
| Withdrawn |
NCT04991038 -
Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients
|
N/A | |
| Completed |
NCT01937182 -
The Efficacy of Citalopram Treatment in Acute Stroke
|
Phase 2 | |
| Completed |
NCT03649295 -
Combined Conventional Speech Therapy and Functional Electrical Stimulation in Dysphagia Following Stroke
|
N/A | |
| Recruiting |
NCT05303649 -
Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia
|
N/A | |
| Completed |
NCT04233515 -
Use of Oral Anticoagulants and Symptoms in Patients With Atrial Fibrillation in Örebro County
|
||
| Completed |
NCT05102877 -
Sensory Versus Motor Level Neuromuscular Electrical Stimulation
|
N/A | |
| Completed |
NCT04089917 -
A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients
|
||
| Completed |
NCT05221112 -
Effects of PNF Patterns Training on Trunk Balance, and Gait in Chronic Stroke Patients
|
N/A | |
| Not yet recruiting |
NCT05035953 -
Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic Stroke
|
Phase 2 | |
| Completed |
NCT06326801 -
Resistive Diaphragmatic Breathing Exercise With Pursed Lips Breathing Exercise in Sub-acute Stroke Patients
|
N/A |