Stimulating the Aging Brain Using Brain and Sensory Stimulation

NCT07650188 | Recruiting FDA Device

• 1 other identifier: PRO00056114
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to investigate whether transcranial electrical stimulation and sensory stimulation affect language outcomes in individuals with primary progressive aphasia (PPA). The main questions it aims to answer are: Does transcranial alternating current stimulation (tACS) affect verbal short-term memory (STM) in individuals with PPA? Does a single session of multisensory stimulation affect verbal STM in individuals with PPA? Researchers will compare active tACS to sham tACS (a fake stimulation condition) to see if active tACS improves verbal STM. Researchers will compare pre-multisensory stimulation to post-stimulation performance to see if multisensory stimulation improves verbal STM. Participants will: Undergo EEG, MRI (anatomical and functional) May complete a cognitive exam Undergo tACS over 3 separate sessions Undergo multisensory stimulation Complete language tasks before, during and/or after stimulation

Conditions

Primary Progressive Aphasia

Keywords

Transcranial alternating current stimulation; Multisensory stimulation

Outcome Measures

Primary Outcomes (2)

• Changes in STM capacity assessed using a verbal STM task

  Improvement in STM capacity with in-phase tACS and worsening of STM capacity with anti-phase tACS compared to sham tACS

  Changes monitored over pre, during and immediately after 20 minutes of tACS

• Changes in STM capacity with multisensory stimulation using a verbal STM task

  Improvement in STM capacity post-stimulation compared to pre-stimulation

  Changes monitored pre and immediately after 20 minutes of stimulation

Study Arms (1)

tACS or multisensory stimulation

EXPERIMENTAL

All participants in a within-subject design will receive high-Definition-tACS, delivered via a battery operated alternating current stimulator (Soterix) using two center-surround montages. Targets of stimulation will be localized based on the 10-10 International EEG system with center electrodes placed at a frontal and a temporoparietal site. The current is turned on and increased in a ramplike fashion over approximately 30 seconds. Participants will undergo tACS with frequencies ranging from 4-40Hz for 20-minutes with 2 milliampere (mA) peak-to-peak intensity. For sham stimulation, tACS is turned off after the first 30 seconds. All participants will receive light and/or sound flicker stimulation using an off-the-shelf app for 20 minutes.

Device: tACS or multisensory stimulation

Interventions

tACS or multisensory stimulation DEVICE

Active or sham tACS Light and/or sound flickers

tACS or multisensory stimulation

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical exam supports diagnosis of PPA and/or MCI with no report of difficulty functioning in basic or instrumental activities of daily living.
• Completed clinical cognitive exam within 6 months of study baseline visit OR neuropsychological research battery within 6 months of study baseline visit.

You may not qualify if:

• Evidence of dementia at baseline
• Known history of neoplasm, symptomatic stroke, moderate to severe traumatic brain injury, or other significant neurologic event
• Age \<45 years.
• Evidence of severe psychiatric illness (e.g., bipolar disorder, schizophrenia).
• Presence of cardiac stimulators or pacemakers
• Any other implants near the scalp or in the eye
• Contraindications to MRI or stimulation
• Pregnancy
• History of ongoing or unmanaged seizures
• History of dyslexia or other developmental learning disabilities

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (6)

• Hu J, Zheng L, Guan Z, Zhong K, Huang F, Huang Q, Yang J, Li W, Li S. Sensory gamma entrainment: Impact on amyloid protein and therapeutic mechanism. Brain Res Bull. 2023 Oct 1;202:110750. doi: 10.1016/j.brainresbull.2023.110750. Epub 2023 Aug 23.

  PMID: 37625524 BACKGROUND

• Iaccarino HF, Singer AC, Martorell AJ, Rudenko A, Gao F, Gillingham TZ, Mathys H, Seo J, Kritskiy O, Abdurrob F, Adaikkan C, Canter RG, Rueda R, Brown EN, Boyden ES, Tsai LH. Gamma frequency entrainment attenuates amyloid load and modifies microglia. Nature. 2016 Dec 7;540(7632):230-235. doi: 10.1038/nature20587.

  PMID: 27929004 BACKGROUND

• Martorell AJ, Paulson AL, Suk HJ, Abdurrob F, Drummond GT, Guan W, Young JZ, Kim DN, Kritskiy O, Barker SJ, Mangena V, Prince SM, Brown EN, Chung K, Boyden ES, Singer AC, Tsai LH. Multi-sensory Gamma Stimulation Ameliorates Alzheimer's-Associated Pathology and Improves Cognition. Cell. 2019 Apr 4;177(2):256-271.e22. doi: 10.1016/j.cell.2019.02.014. Epub 2019 Mar 14.

  PMID: 30879788 BACKGROUND

• McNett SD, Vyshedskiy A, Savchenko A, Durakovic D, Heredia G, Cahn R, Kogan M. A Feasibility Study of AlzLife 40 Hz Sensory Therapy in Patients with MCI and Early AD. Healthcare (Basel). 2023 Jul 17;11(14):2040. doi: 10.3390/healthcare11142040.

  PMID: 37510481 BACKGROUND

• Tang Y, Xing Y, Sun L, Wang Z, Wang C, Yang K, Zhu W, Shi X, Xie B, Yin Y, Mi Y, Wei T, Tong R, Qiao Y, Yan S, Wei P, Yang Y, Shan Y, Zhang X, Jia J, Teipel SJ, Howard R, Lu J, Li C, Zhao G. TRanscranial AlterNating current stimulation FOR patients with mild Alzheimer's Disease (TRANSFORM-AD): a randomized controlled clinical trial. Alzheimers Res Ther. 2024 Sep 12;16(1):203. doi: 10.1186/s13195-024-01570-0.

  PMID: 39267112 BACKGROUND

• Altomare D, Benussi A, Cantoni V, Premi E, Rivolta J, Cupidi C, Martorana A, Santarnecchi E, Padovani A, Koch G, Borroni B. Home-based transcranial alternating current stimulation (tACS) in Alzheimer's disease: rationale and study design. Alzheimers Res Ther. 2023 Sep 15;15(1):155. doi: 10.1186/s13195-023-01297-4.

  PMID: 37715232 BACKGROUND

MeSH Terms

Conditions

Aphasia, Primary Progressive

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Priyanka Shah-Basak, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sidney Schoenrock, MA

CONTACT

414-955-7579; sschoenrock@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants and personnel scoring the outcomes will be blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Model Details: In a within-subject design, participants will receive in-phase tACS, anti-phase tACS and sham tACS with spatial targets and tACS frequency guided by baseline fMRI and EEG results. Participants will also undergo multisensory stimulation using light and/or sound flickers provided in the gamma range during a session separate from tACS.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 30, 2031
• Study Completion (Estimated): May 30, 2035
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)