Nexalin’s DIFS™ Neurostimulation Shows Cognitive and Brain Network Improvements in Alzheimer’s and Dementia Across Three Peer-Reviewed Studies

Rhea-AI Summary

Nexalin Technology (Nasdaq: NXL) announced three independently peer‑reviewed studies (Alzheimer's Research & Therapy; Journal of Alzheimer’s Disease; Radiology) showing cognitive and network benefits from its 15 mA Gen‑2 Deep Intracranial Frequency Stimulation (DIFS) device.

Key study details: a randomized double‑blind trial (46 patients) used 30 one‑hour DIFS sessions over 15 days with immediate MMSE and MoCA gains; fMRI studies reported increased hippocampal activation, fALFF, ReHo and improved hippocampus–cortex connectivity. The company frames DIFS as a non‑invasive, drug‑free alternative with no reported serious side effects.

Positive

• Randomized trial of 46 patients reported immediate MMSE/MoCA improvements
• 30 one‑hour sessions delivered over a 15‑day treatment course
• Radiology June 2025 paper linked cognitive gains to hippocampus–cortex connectivity
• fMRI signals improved (increased fALFF, ReHo, low‑frequency fluctuations)

Negative

• Small randomized sample (46 patients) limits generalizability
• No regulatory approval or cleared indication is mentioned in the announcement

Insights

Clinical Neuroscience Analyst

Three independent peer-reviewed studies report cognitive and network-level improvements from Nexalin's DIFS™, supporting further clinical development.

Nexalin shows convergent evidence across randomized clinical and imaging studies that its 15 mA Gen-2 DIFS™ protocol produced short-term cognitive gains (MMSE, MoCA) and reproducible fMRI markers of restored network function, including hippocampal theta-gamma coupling, increased fALFF/ReHo, and strengthened hippocampal–cortical connectivity. The data set spans a randomized double-blind trial (46 patients, 30 one-hour sessions over 15 days) and two independent resting‑state and connectivity analyses, creating a multi-modal link between observed imaging changes and measured cognition.

The primary dependencies and risks are clear from the disclosed facts: durability beyond the reported short-term window is not stated, sample sizes are limited (the randomized trial reports 46 patients), and regulatory advancement requires replication in larger, prespecified pivotal studies. Safety is described as having “no reported serious side effects,” but full safety summaries and longer-term tolerability data are not provided here. Watch for larger randomized, controlled trials and registrational study designs, along with prespecified cognitive endpoints and adverse‑event summaries over months to years; near-term milestones include publication dates already listed (e.g., June 2025 and Oct 21, 2025) and any announced trial initiations or regulatory filings within the next 12–36 months.

Three Independent Studies Published in “Alzheimer’s Research & Therapy,” “Journal of Alzheimer’s Disease,” and “Radiology” Validate Nexalin’s Non-Invasive Approach with Consistent Cognitive and Neuroimaging Benefits

HOUSTON, TX, Oct. 21, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced that three independently published, peer-reviewed clinical studies, coupled with a growing body of internal data, collectively demonstrate the ability of its proprietary 15 milliamp (mA) Gen-2 Nexalin DIFS™ technology—to improve cognition, restore brain activity, and enhance neuron connectivity in patients with Alzheimer’s disease (AD).

Each study was announced separately upon publication. Taken together, the results provide a convergent body of evidence validating Nexalin’s differentiated, non-invasive approach to treating Alzheimer’s disease.

1. TRANSFORM-AD – Alzheimer’s Research & Therapy
This randomized, double-blind clinical trial (46 patients) evaluated 30 one-hour DIFS sessions over 15 days. Patients receiving active stimulation demonstrated immediate improvements in MMSE and MoCA scores, alongside enhanced hippocampal theta-gamma coupling and increased low-frequency fluctuations on fMRI. The study provided the first rigorous evidence of hippocampal activation and short-term cognitive benefit from DIFS in Alzheimer’s and Dementia.

2. Altered Neuronal Activity – Journal of Alzheimer’s Disease
A subsequent publication used resting-state fMRI to analyze brain network changes. Results demonstrated significant increases in fALFF and regional homogeneity (ReHo) in key prefrontal and memory-related regions, including the left middle frontal gyrus and right parahippocampal gyrus. These findings underscored DIFS’ ability to restore regional neuronal synchronization and blood flow in disrupted networks.

3. Modulation of Cortical and Hippocampal Connectivity – Radiology
The most recent publication, appearing in Radiology (June 2025), showed that DIFS significantly improved cognition while enhancing connectivity between the hippocampus and cortical regions, including the middle cingulate and middle frontal gyri. Network-level gains were also observed across the default mode and frontoparietal networks—systems critical to memory and executive function. Notably, cognitive improvements correlated with imaging findings, directly linking brain network modulation to functional outcomes.

With the global Alzheimer’s market projected to exceed $20 billion annually, current treatments remain dominated by pharmacologic therapies targeting amyloid or tau proteins. These drugs, while representing some progress, often deliver modest clinical benefits, and carry significant safety risks and high costs.

Nexalin’s DIFS technology is fundamentally different:

• Drug-free and non-invasive, with no reported serious side effects.
• Targeted to network dysfunction, addressing disrupted brain connectivity rather than protein accumulation.
• Safe and scalable, with demonstrated tolerability in elderly patients.

The Company believes this will position Nexalin as a potential paradigm-shifting solution for patients seeking accessible, safe, effective alternatives to drug regimens, at considerably less cost than pharmaceuticals.

“The strength of these three publications lies in their convergence,” said Mark White, CEO of Nexalin Technology. “Each study explores a different dimension of the disease—cognition, regional activity, and functional connectivity—and all point to the same conclusion: Nexalin’s DIFS technology has the potential to restore brain networks and improve cognitive function in Alzheimer’s disease. Collectively, they represent one of the most compelling non-invasive data sets to date in this field.”

Dr. David Owens, Chief Medical Officer of Nexalin, added, “These studies together validate the mechanism of action for DIFS. By showing consistent improvements across multiple imaging modalities and clinical outcomes, we now have a holistic picture of how DIFS may counteract the disruptions that drive cognitive decline in Alzheimer’s. This growing body of evidence strongly supports further development and regulatory advancement.”

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, 2024 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. 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

What did Nexalin (NXL) announce on October 21, 2025 about DIFS clinical evidence?

Nexalin announced three peer‑reviewed studies showing cognitive and fMRI network improvements from its 15 mA Gen‑2 DIFS device.

What were the treatment details in Nexalin's TRANSFORM‑AD trial (NXL)?

TRANSFORM‑AD randomized 46 patients to 30 one‑hour DIFS sessions delivered over 15 days, reporting immediate MMSE and MoCA improvements.

Which imaging results supported Nexalin's (NXL) cognitive claims?

Published fMRI findings showed increased hippocampal theta‑gamma coupling, higher fALFF and ReHo, and stronger hippocampus–cortex connectivity.

Does Nexalin (NXL) report any serious side effects from DIFS in these studies?

The announcement states DIFS is drug‑free and non‑invasive with no reported serious side effects.

How do Nexalin's (NXL) published papers link imaging to clinical benefit?

The Radiology paper (June 2025) reported that cognitive improvements correlated with imaging changes in default mode and frontoparietal networks.

What investor risks remain after Nexalin's (NXL) study publications?

Risks include limited sample size in the randomized trial and absence of any mentioned regulatory approvals or cleared indications.