The NexSpeech® 2 module comprises the following components:
1. NexSpeech Presentation Set, including:
- LCD unit for displaying image stacks to the patient
- Video camera for recording speech behavior in baseline and stimulation sessions
2. NexSpeech Camera and Display Holder
3. Single-use NexSpeech Head Tracker
4. NexSpeech 2 main software and Analyzer software (installed on NBS System PC)
Other components are Nexstim NBS System devices.
Nexstim NBS® System 5 and NexSpeech are cleared by the Food and Drug Administration (FDA, K112881).
The Nexstim Navigated Brain Stimulation (NBS) System 5 is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus.
The Nexstim NBS System 5 provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning.
Nexstim NexSpeech®, when used together with the NBS System 5, is indicated for non-invasive localization of cortical areas that do not contain essential speech function. NexSpeech® provides information that may be used in pre-surgical planning in patients undergoing brain surgery.
Intra-operatively, the localization information provided by NexSpeech® is intended to be verified by direct cortical stimulation.The Nexstim NBS System 5 and NBS System 5 with NexSpeech® are not intended to be used during a surgical procedure. The Nexstim NBS System 5 and NBS System 5 with NexSpeech® are intended to be used by trained clinical professionals.
nTMS makes surgery safer, the resection rates are higher and—in the end—the outcomes are better.
Bernhard Meyer, MD, Professor & Chair,
Department of Neurosurgery, Klinikum rechts der Isar, Technical University of Munich, Germany.