- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Sidney Schoenrock, MA
- Telefonnummer: 414-955-7579
- E-post: sschoenrock@mcw.edu
Studieorter
-
-
Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Rekrytering
- Medical College of Wisconsin
-
Kontakt:
- Sidney Schoenrock, MA
- Telefonnummer: 414-955-7579
- E-post: sschoenrock@mcw.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in STM capacity assessed using a verbal STM task
Tidsram: Changes monitored over pre, during and immediately after 20 minutes of tACS
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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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Priyanka Shah-Basak, PhD, Medical College of Wisconsin
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Mentala störningar
- Neurobehavioral manifestationer
- Neurokognitiva störningar
- Demens
- Kommunikationsstörningar
- Språkstörningar
- Afasi
- Talstörningar
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Afasi, Primär progressiv
Andra studie-ID-nummer
- PRO00056114
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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