BrainsWay Pilot Study Links Deep TMS to Depression Improvement in Early Alzheimer’s Patients

Key Points

• BrainsWay reported results from a 12-patient pilot study of Deep TMS in people with major depressive disorder and early-stage Alzheimer’s disease.
• After 36 treatment sessions, 83.3% of participants met the study’s definition of depression response and 50% met the definition of remission.
• Researchers also reported changes in brain-activity and connectivity measurements taken before and after treatment.
• The findings were published in the peer-reviewed Journal of Geriatric Psychiatry and Neurology.
• Deep TMS is not FDA-cleared to treat Alzheimer’s disease, and larger controlled studies will be needed to evaluate the early findings.

BrainsWay (NASDAQ: BWAY) has reported encouraging pilot-study results for its Deep Transcranial Magnetic Stimulation, or Deep TMS, technology in patients living with both major depressive disorder and early-stage Alzheimer’s disease.

The peer-reviewed study involved 12 patients and was conducted by researchers from the Delray Center for Brain Science and Florida Atlantic University’s Department of Psychology. Participants received 36 Deep TMS treatment sessions using BrainsWay’s H1 and H7 coils.

Study Reports High Depression Response and Remission Rates

The study reported that 83.3% of participants experienced a response in depressive symptoms. Researchers defined a response as at least a 50% reduction on the Patient Health Questionnaire-9, or PHQ-9, depression rating scale.

Half of the participants reached remission, defined as a PHQ-9 score of 4 or less, after treatment.

The results relate to depressive symptoms in patients with both depression and early-stage Alzheimer’s disease. The study does not establish that Deep TMS treats Alzheimer’s disease itself, slows cognitive decline, or changes the course of the neurodegenerative condition.

Treatment Stimulated Brain Regions Linked to Depression and Alzheimer’s Disease

Researchers used BrainsWay’s H1 coil to stimulate the left dorsolateral prefrontal cortex, a brain area associated with mood regulation.

They then used the H7 coil to stimulate temporal brain regions. The treatment approach aimed to engage brain networks that may be relevant to both depression and Alzheimer’s-related neurological changes.

Deep TMS is a noninvasive neurostimulation treatment that uses magnetic fields to stimulate targeted areas of the brain. The study evaluated the technology’s effect on depressive symptoms and measured changes in brain electrical activity.

Brain Measurements Showed Changes After Treatment

Researchers used quantitative electroencephalography, or QEEG, to compare brain-activity patterns before and after treatment.

The study identified reduced delta-frequency power in the right temporal lobe after Deep TMS. Delta activity refers to low-frequency brain waves between 0 and 3 Hz. The researchers said the reduction could suggest less cortical slowing, a pattern often associated with Alzheimer’s disease.

The study also reported increased alpha coherence between several frontal and temporal regions. Alpha coherence measures synchronization and functional connectivity among brain regions. The researchers said the changes could indicate improvement in disrupted brain connectivity associated with Alzheimer’s disease.

These findings are preliminary. The small study size and lack of information here on a control group mean the results cannot establish that Deep TMS caused the reported brain changes or clinical improvements.

BrainsWay Calls Results an Early Scientific Signal

BrainsWay Chief Executive Officer Hadar Levy said the response and remission results, along with the neurophysiological measurements, represent an encouraging scientific signal that warrants further study.

The company said the research adds to the broader body of work exploring Deep TMS in complex psychiatric and neurological patient groups.

For investors, the report provides published early-stage evidence supporting additional investigation of Deep TMS in a population with depression and early Alzheimer’s disease. It does not create a new FDA-cleared indication, establish a regulatory pathway, or provide a commercial-development timeline.

Deep TMS is not FDA-cleared for the treatment of Alzheimer’s disease. Larger, controlled clinical research will be required to assess safety, effectiveness, durability of response, and whether the treatment has any effect on Alzheimer’s disease progression.