Nexalin Technology Announces Planned Clinical Trial Utilizing Gen-3 Halo Headset in Partnership with UC San Diego & San Diego VA
Nexalin Technology (NXL) has announced plans for a new clinical trial in collaboration with UC San Diego and San Diego VA. The study will evaluate the effectiveness of Nexalin's Gen-3 Halo headset in treating veterans with mild Traumatic Brain Injury (mTBI) using a virtual clinic model. This innovative approach allows patients to receive treatment at home, potentially expanding access to care.
The trial builds on positive results from a previous study using Nexalin's Gen-2 device, which showed significant improvements in MEG signals and pain reduction for mTBI patients. The Gen-3 Halo headset incorporates Nexalin's proprietary Deep Intracranial Frequency Stimulation (DIFS®) technology with an advanced 15 milliamp waveform.
The study will recruit two groups: one receiving treatment with the Nexalin Gen-3 Halo headset and another using a sham device for comparison. It aims to assess changes in brain activity and correlate them with improvements in post-concussion symptoms and neuropsychological test performance.
Nexalin Technology (NXL) ha annunciato piani per un nuovo trial clinico in collaborazione con l'UC San Diego e il San Diego VA. Lo studio valuterà l'efficacia del casco Gen-3 Halo di Nexalin nel trattamento dei veterani con lieve trauma cranico (mTBI) utilizzando un modello di clinica virtuale. Questo approccio innovativo consente ai pazienti di ricevere trattamenti a casa, potenzialmente ampliando l'accesso alle cure.
Il trial si basa su risultati positivi di uno studio precedente che utilizzava il dispositivo Gen-2 di Nexalin, il quale ha mostrato miglioramenti significativi nei segnali MEG e nella riduzione del dolore per i pazienti mTBI. Il casco Gen-3 Halo incorpora la tecnologia proprietaria di Nexalin denominata Deep Intracranial Frequency Stimulation (DIFS®) con un avanzato waveform a 15 milliamp.
Lo studio recluterà due gruppi: uno che riceverà il trattamento con il casco Gen-3 Halo di Nexalin e un altro che utilizzerà un dispositivo fittizio per il confronto. L'obiettivo è valutare i cambiamenti nell'attività cerebrale e correlare questi cambiamenti con i miglioramenti nei sintomi post-concussione e nelle performance ai test neuropsicologici.
Nexalin Technology (NXL) ha anunciado planes para un nuevo ensayo clínico en colaboración con UC San Diego y San Diego VA. El estudio evaluará la efectividad del auricular Gen-3 Halo de Nexalin en el tratamiento de veteranos con lesión cerebral traumática leve (mTBI) utilizando un modelo de clínica virtual. Este enfoque innovador permite a los pacientes recibir tratamiento en casa, potencialmente ampliando el acceso a la atención.
El ensayo se basa en resultados positivos de un estudio anterior que utilizaba el dispositivo Gen-2 de Nexalin, que mostró mejoras significativas en las señales MEG y reducción del dolor para pacientes con mTBI. El auricular Gen-3 Halo incorpora la tecnología patentada de Nexalin llamada Deep Intracranial Frequency Stimulation (DIFS®) con una forma de onda avanzada de 15 miliamperios.
El estudio reclutará dos grupos: uno que recibirá tratamiento con el auricular Gen-3 Halo de Nexalin y otro que usará un dispositivo de placebo para comparación. Su objetivo es evaluar los cambios en la actividad cerebral y correlacionarlos con mejoras en los síntomas posteriores a la conmoción cerebral y el rendimiento en pruebas neuropsicológicas.
넥살린 테크놀로지(NXL)는 UC 샌디에고 및 샌디에고 VA와 협력하여 새로운 임상 시험 계획을 발표했습니다. 이 연구는 가벼운 외상성 뇌 손상을(mTBI) 가진 재향군인들을 치료하기 위해 넥살린의 Gen-3 헤일로 헤드셋의 효과를 평가할 것입니다. 이 혁신적인 접근 방식은 환자가 집에서 치료를 받을 수 있게 하여 치료 접근성을 확대할 잠재력이 있습니다.
이 시험은 넥살린의 Gen-2 장치를 사용한 이전 연구에서 긍정적인 결과를 바탕으로 진행되며, 그 연구에서는 mTBI 환자에서 MEG 신호와 통증 감소에 중요한 개선이 나타났습니다. Gen-3 헤일로 헤드셋은 15 밀리암페어의 고급 파형과 함께 넥살린의 독점 심부 두개 내 주파수 자극(DIFS®) 기술을 통합합니다.
연구는 두 그룹을 모집할 예정입니다: 하나는 넥살린의 Gen-3 헤일로 헤드셋으로 치료를 받고, 다른 하나는 비교를 위해 sham 장치를 사용할 것입니다. 목표는 뇌 활동의 변화를 평가하고 이를 뇌진탕 후 증상 개선 및 신경심리 테스트 성능과 연관 짓는 것입니다.
Nexalin Technology (NXL) a annoncé des projets pour un nouvel essai clinique en collaboration avec l'UC San Diego et le San Diego VA. L'étude évaluera l'efficacité du casque Gen-3 Halo de Nexalin dans le traitement des vétérans atteints de légère lésion cérébrale traumatique (mTBI) en utilisant un modèle de clinique virtuelle. Cette approche innovante permet aux patients de recevoir des traitements à domicile, ce qui pourrait élargir l'accès aux soins.
L'essai repose sur des résultats positifs d'une étude précédente utilisant le dispositif Gen-2 de Nexalin, qui a montré des améliorations significatives des signaux MEG et une réduction de la douleur chez les patients souffrant de mTBI. Le casque Gen-3 Halo intègre la technologie propriétaire de Nexalin appelée Deep Intracranial Frequency Stimulation (DIFS®), avec une forme d'onde avancée à 15 milliampères.
L'étude recrutera deux groupes : l'un recevant un traitement avec le casque Gen-3 Halo de Nexalin et l'autre utilisant un dispositif placebo pour la comparaison. Elle vise à évaluer les changements dans l'activité cérébrale et à les mettre en corrélation avec les améliorations des symptômes post-concussion et des performances aux tests neuropsychologiques.
Nexalin Technology (NXL) hat Pläne für eine neue klinische Studie in Zusammenarbeit mit der UC San Diego und dem San Diego VA angekündigt. Die Studie wird die Wirksamkeit des Gen-3 Halo-Headsets von Nexalin zur Behandlung von Veteranen mit leichten traumatischen Hirnverletzungen (mTBI) in einem virtuellen Klinikmodell bewerten. Dieser innovative Ansatz ermöglicht es den Patienten, die Behandlung zu Hause zu erhalten, was den Zugang zur Versorgung möglicherweise erweitert.
Die Studie baut auf positiven Ergebnissen einer früheren Studie mit dem Gen-2-Gerät von Nexalin auf, die signifikante Verbesserungen bei MEG-Signalen und Schmerzlinderung für mTBI-Patienten zeigte. Das Gen-3 Halo-Headset integriert die proprietäre Deep Intracranial Frequency Stimulation (DIFS®)-Technologie von Nexalin mit einer fortschrittlichen 15-Milliampere-Welleform.
Die Studie wird zwei Gruppen rekrutieren: eine, die mit dem Nexalin Gen-3 Halo-Headset behandelt wird, und eine andere, die ein sham-Gerät zum Vergleich verwendet. Ziel ist es, Veränderungen in der Gehirnaktivität zu bewerten und diese mit Verbesserungen der Symptome nach einer Gehirnerschütterung und der Leistung in neuropsychologischen Tests zu korrelieren.
- Collaboration with prestigious institutions UC San Diego and San Diego VA for clinical trial
- Gen-3 Halo headset offers convenient at-home treatment through virtual clinic model
- Building on positive results from previous clinical trial treating veterans with mTBI
- Potential to expand access to care for veterans suffering from mTBI
- Alignment with Veterans Administration's objective of expanding therapeutic telehealth services
- Clinical trial results are not guaranteed and may not replicate previous positive outcomes
- Regulatory approval for the Gen-3 Halo headset is still pending
- Market adoption of virtual clinic model for neuromodulation treatments is uncertain
Insights
This planned clinical trial for Nexalin's Gen-3 Halo headset represents a significant step forward in mTBI treatment. The study's focus on at-home treatment via a virtual clinic model addresses key barriers to care for veterans, aligning with the VA's telehealth objectives. The 15 milliamp waveform technology, building on previous positive results, could potentially offer more accessible and effective treatment for mTBI symptoms.
The trial's design, incorporating MEG signal analysis and a sham control group, provides a robust framework for evaluating the headset's efficacy. If successful, this could lead to:
- Improved access to care for veterans with mTBI
- Reduced stigma associated with mental health treatment
- Potential cost savings in long-term veteran care
However, investors should note that clinical trials carry inherent risks and positive outcomes are not guaranteed. The study's results will be important in determining the Gen-3 Halo headset's market potential and Nexalin's future in the
This clinical trial announcement could have significant implications for Nexalin's financial prospects. Key points for investors:
- Market Opportunity: The VA's
$17 billion budget for veterans' mental health services represents a substantial potential market. - Cost-Effective Solution: If successful, the at-home treatment model could reduce healthcare delivery costs, making it attractive to both the VA and private insurers.
- Competitive Advantage: The proprietary DIFS® technology and virtual clinic model could position Nexalin uniquely in the neuromodulation market.
- Regulatory Pathway: Positive trial results could accelerate FDA approval processes, potentially leading to faster market entry.
However, investors should consider that Nexalin, with a market cap of
Gen-3 Halo Headset Designed to Offer Convenient At-Home Treatment Through Virtual Clinic Model
Study to Build on Positive Results from Previous Clinical Trial Treating Veterans with Mild Traumatic Brain Injury (mTBI)
HOUSTON, TX, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) today announced plans to commence a new clinical trial in collaboration with the University of California, San Diego (UCSD). Dr Ming Xiong Huang, the UCSD principal investigator, will utilize his affiliation with the San Diego VA to recruit some of the patients for the study who have been victims of Traumatic Brain Injury (TBI). This trial will focus on the effectiveness of Nexalin’s next-generation Gen-3 Halo headset, designed to be used in a virtual clinic model, allowing patients to receive treatment from the convenience and privacy of their own home thus overriding the inconvenience and stigma of visiting a psychiatry office or VA Hospital. This breakthrough approach aims to expand access to care for veterans suffering from mild Traumatic Brain Injury (mTBI) without the need for frequent hospital or clinic visits.
The Gen-3 Halo headset incorporates Nexalin’s proprietary Deep Intracranial Frequency Stimulation (DIFS®) technology, utilizing an advanced 15 milliamp waveform. Building on the success of a previous trial using the Gen-2 15 mAmp console device, the Gen-3 model offers enhanced convenience for in-home treatment while maintaining clinical precision. The new trial will seek to replicate the earlier results, which showed significant improvements in MEG (magnetoencephalography) signals and reductions in pain symptoms for mTBI patients.
The study titled, “MEG Study of the Transcranial Electrical Stimulation Treatment for Mild Traumatic Brain Injury using the Nexalin Halo Headset that Utilizes the Advanced 15 Milliamp Waveform,” will evaluate the effects of Nexalin’s Gen-3 Halo headset on brain activity and symptom relief in veterans, all while leveraging the ease and accessibility of virtual treatment.
Nexalin’s program is aligned with the Veterans Administration’s stated objective of expanding therapeutic telehealth services and expertise for veterans suffering with mTBI, as indicated in their 2025 Professional Judgement Budget. This budget also included over
Study Design and Objectives
This research will interpret MEG signals to assess the effectiveness of the Gen-3 Halo headset’s Deep Intracranial Frequency Stimulation (DIFS®) technology in individuals with mTBI. The virtual clinic model is a key component, enabling participants to receive treatment remotely, reducing the barriers to accessing care. The study aims to detect the location of injury and assess the mechanisms underlying neuroimaging changes associated with the treatment. It will measure changes in abnormal MEG slow-wave (1-4 Hz) and gamma-activity (30-80 Hz) generation and correlate them with improvements in post-concussion symptoms (PCS) and neuropsychological test performance.
The trial will recruit two groups of mTBI participants:
- Group 1 (minimum 20, maximum 40): Participants randomly assigned to receive treatment with the Nexalin Gen-3 Halo headset.
- Group 2 (minimum 10, maximum 20): Participants randomly assigned to a sham device for comparison.
The study is expected to provide important insights into the mechanisms of mTBI and demonstrate the therapeutic efficacy of Nexalin’s Gen-3 Halo headset, which offers the added benefit of virtual, at-home treatment.
Enhanced Access to Care with the Gen-3 Halo Headset
Nexalin’s Gen-3 Halo headset represents a significant advancement in neuromodulation technology, specifically designed for in-home use within a virtual clinic model. This innovative approach not only enhances patient convenience but also ensures consistent, targeted treatment with the advanced 15 mAmp waveform. The device is a key part of Nexalin’s broader strategy to expand access to treatment while maintaining clinical-grade precision in a home setting.
Building on Promising Results from Previous Trials
Last year, UCSD conducted a clinical trial using Nexalin’s Gen-2 console device to treat veterans with mTBI. The study showed notable improvements in brain activity and pain reduction among participants in the active treatment group compared to the sham group. The success of this trial laid the groundwork for further exploration of Nexalin’s technology, now adapted for at-home use with the Gen-3 Halo headset.
“We are once again partnering with UC San Diego to bring the added benefit of a virtual clinic model to our veterans,” said Mark White, CEO of Nexalin Technology. “Our Gen-3 Halo headset allows patients to receive treatment from the comfort of their homes, making care more accessible and less intrusive while maintaining the precision of our DIFS® technology. We believe this new trial could significantly enhance our understanding of mTBI and further validate the efficacy of our advanced neuromodulation device.”
About Nexalin Technology, Inc.
Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. All of Nexalin’s products are believed to be non-invasive and undetectable to the human body and are developed to provide relief to those afflicted with mental health issues. Nexalin utilizes bioelectronic medical technology to treat mental health issues. Nexalin believes its neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper-penetrating waveform in its next-generation devices will generate enhanced patient response without any adverse side effects. The Nexalin Gen-2 15 milliamp neurostimulation device has been approved in China, Brazil, and Oman. Additional information about the Company is available at: https://nexalin.com/.
FORWARD-LOOKING STATEMENTS
This press release contains statements that constitute “forward-looking statements,” These statements relate to future events or Nexalin’s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that Nexalin or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward looking statements that involve risks and uncertainties which could cause actual events or Nexalin’s actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Report on Form 10-K for the year ended December 31, 2023 and other filings as filed with the Securities and Exchange Commission. Copies of such filings are available on the SEC’s website, www.sec.gov. Such forward-looking statements are made as of the date hereof and may become outdated over time. Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
Contact:
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com
FAQ
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