Phase 2 Study Highlights Therapeutic Potential of Nexalin's Transcranial Electrical Stimulation Device in TBI

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Overall, the reduction of hyperactivity of delta- and gamma-band activities in mTBI suggest the treatment may reduce deafferentation and GABA-ergic inhibitory interneuron dysfunctions.

Mark White, chief executive officer at Nexalin

Mark White

Newly announced findings from a placebo-controlled trial showed that treatment with Nexalin’s Gen-2 transcranial electrical stimulation (tES) device resulted in significant reductions in delta-band activity and abnormal gamma-band activity in veterans with mild traumatic brain injury (mTBI). Overall, the data showcased the therapeutic potential of this approach, as well as demonstrated the functionality of resting-state magnetoencephalography (rs-MEG) as an imaging technique to assess neuronal changes from tES treatment.1,2

The double-blind, randomized trial included 24 veterans with mTBI who received 12 sessions of active (n = 15) or sham tACS (n = 9) over a 4-week period, followed by a 4-week follow-up. In each session, the Nexalin tES pulses were at 15 mA current, through 3 electrodes placed at the forehead and left-right mastoids, with 3 repetition frequencies at 4 Hz, 40 Hz, and 77.5 HZ, and around 20 minutes for each frequency. In total, 10 participants finished the 12-session active (n = 7) or sham (n = 3) treatments but without both pre- and post-treatment rs-MEG, whereas 9 did not finish the active (n = 5) or sham (n = 4) treatment.

All told, results showed that the treatment was safe, with only 1 participant noting discomfort during impedance checking because of poor electrode-skin contact. Compared with the sham group, veterans on active treatment displayed significant reductions in delta-band activity mainly in the frontal pole and inferior frontal gyri, suggesting improvement in differentiation. Furthermore, this group also had reduced abnormal gamma-band activity mainly driven from the frontal pole, orbital frontal cortex, and posterior parietal regions, suggesting improvement in GABA-ergic inhibitory interneuron functions.

"We are encouraged by the results of the clinical study, reinforcing the significant reduction in pain and other persistent symptoms of mild traumatic brain injury among veteran patients," Mark White, chief executive officer at Nexalin, said in a statement. "We look forward to further discussing the data at BARDA’s prestigious upcoming event. Importantly, this latest study builds on prior data in combat-related mTBI disclosed at the 2023 Military Health System Research Symposium (MHSRS) and validates the growing body of clinical evidence supporting Nexalin's new advanced 15 milliamp waveform."

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Post-concussive symptoms (PCS) were assessed through the Rivermead Post-Concussion Symptoms Questionnaire (RPQ), Neurobehavioral Symptom Inventory (NSI), and McGill Pain Questionnaire (MPQ). In comparison with sham, the data showed that treatment with Nexalin’s tES reduced RPQ and NSI symptoms; however, this did not reach statistical significance, which authors noted may have been in part because of the limited sample size and the failure of 10 patients to fully complete treatments.

After the initiation of Nexalin’s tES, investigators observed a significant reduction in pain (P = .00031), demonstrated through the MPQ, that was also more significantly pronounced that the sham group (P = .0027). Overall, the study authors concluded that a trial with a larger sample size may be needed to further validate these initial results and to study the associations of MEG measures with changes in clinical outcomes.

White added, "We believe the data we have reported provides evidence of the potential clinical efficacy of our neurostimulation device on improving mental healthcare outcomes among patients affected with mTBI, without any significant adverse effects. This is especially noteworthy given the growing number of patients seeking non-pharmacological treatment options. Additionally, it is further gratifying to learn from the results of our MEG studies that Nexalin therapy truly is a non-invasive deep brain stimulating tool, which can result in lasting therapeutic neuroplastic changes in brain disorders. We look forward to advancing the technology within the military and government agencies to bring hope to countless numbers of military and civilian patients impacted by these often-debilitating conditions in the United States and around the world."

In late 2023, Nexalin announced topline data from a randomized, controlled study showing that its tES treatment may be beneficial in patients with migraine. Conducted at the Vertigo Center at the Second Affiliated Hospital of Zhengzhou University, the trial included 40 individuals who were assigned to either neuromodulation or sham for a 4-week treatment period. All told, patients on active treatment experienced statistically significant improvements in all key metrics, including Visual Analog Scale, Pittsburgh Sleep Quality Index, Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, and Migraine-Specific Quality of Life Questionnaire scores.3

REFERENCES
1. Nexalin Technology announces positive results of clinical study validating its Gen-2 tACS device for reducing pain among veterans with mild traumatic brain injury at University of California, San Diego. News release. Nexalin Technology. March 28, 2024. Accessed April 1, 2024. https://www.globenewswire.com/news-release/2024/03/28/2854008/0/en/Nexalin-Technology-Announces-Positive-Results-of-Clinical-Study-Validating-its-Gen-2-tACS-Device-for-Reducing-Pain-Among-Veterans-with-Mild-Traumatic-Brain-Injury-at-University-of-.html
2. Huang M, Angeles-Quinto A, Baker D, et al. MEG source imaging reveals neuronal changes in combat-related mild traumatic brain injury after transcranial electrical stimulation using Nexalin. Accessed April 1, 2024. https://drive.google.com/file/d/1B5rFTU3a23Mo5l7RUg562D4QUevQCmW4/view?pli=1
3. Nexalin Technology reports results of clinical study supporting the therapeutic benefits of its Gen-2, 15 milliamp neurostimulation device in treating migraine headaches and related symptoms. Nexalin Technology. August 7, 2023. Accessed April 1, 2024. https://www.globenewswire.com/news-release/2023/08/07/2719691/0/en/Nexalin-Technology-Reports-Results-of-Clinical-Study-Supporting-the-Therapeutic-Benefits-of-its-Gen-2-15-Milliamp-Neurostimulation-Device-in-Treating-Migraine-Headaches-and-Related.html
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