- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07650188
Stimulating the Aging Brain Using Brain and Sensory Stimulation (StAB)
Stimulating the Aging Brain: Noninvasive Brain and Sensory Stimulation Strategies in Aging
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sidney Schoenrock, MA
- Phone Number: 414-955-7579
- Email: sschoenrock@mcw.edu
Study Locations
-
-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Medical College of Wisconsin
-
Contact:
- Sidney Schoenrock, MA
- Phone Number: 414-955-7579
- Email: sschoenrock@mcw.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: tACS or multisensory stimulation
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. |
Active or sham tACS Light and/or sound flickers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in STM capacity assessed using a verbal STM task
Time Frame: Changes monitored over pre, during and immediately after 20 minutes of tACS
|
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
Time Frame: Changes monitored pre and immediately after 20 minutes of stimulation
|
Improvement in STM capacity post-stimulation compared to pre-stimulation
|
Changes monitored pre and immediately after 20 minutes of stimulation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Priyanka Shah-Basak, PhD, Medical College of Wisconsin
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Dementia
- Communication Disorders
- Language Disorders
- Aphasia
- Speech Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Aphasia, Primary Progressive
Other Study ID Numbers
- PRO00056114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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