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- Klinische Studie NCT01958437
Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation
Remembering how to travel from one location to another is critical in everyday life, yet this vital ability declines with normal aging and can be further affected by conditions that disproportionately affect the elderly, such as vision loss or progressive dementia. Human and animal research has shown that two distinct memory systems interact during navigation. The first, referred to as allocentric navigation, is very flexible and uses spatial knowledge of key features or landmarks to develop and use a mental map of the environment. This approach involves brain regions that are critical for new learning and memory but that decline with age. The second, referred to as egocentric navigation, is inflexible and relies on "habit" memories that link specific features with specific directions. This approach relies on brain regions that are critical for "automatic" responses and that are relatively unaffected by age.
The main problem is that allocentric navigation declines with age and is accompanied increased dependence on egocentric navigation. This change increases the risk of becoming disoriented or "lost" when traveling in unfamiliar areas or even when traveling new routes in familiar areas. Therefore, the main goal of this project is to examine whether non-invasive brain stimulation, specifically transcranial direct current stimulation, can improve allocentric navigation in healthy older adults and patients with mild cognitive impairment.
Participants will complete two functional magnetic resonance imaging sessions while learning new environments. Before one of these sessions, participants will receive active brain stimulation over the parietal cortex. Before the other session, participants will receive sham brain stimulation over the parietal cortex. The effects of this stimulation will be evaluated using both an allocentric and an egocentric memory test. Physiologic effects will be evaluated using both task-based and resting-state MRI.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Georgia
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Decatur, Georgia, Vereinigte Staaten, 30033
- Atlanta VA Medical and Rehab Center, Decatur, GA
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
General inclusion criteria (all participants):
- All medications stable for approximately 1-2 months;
- No history of severe mental illness;
- No current untreated alcohol or substance abuse/dependence;
- English as native and preferred language;
- MRI-compatible if taking part in fMRI studies
- Able to give informed consent.
MCI Inclusion Criteria:
- Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004). Additionally, other potential causes of cognitive deficit ruled out by the referring physician;
Healthy older adults
- intact cognitive functioning as measured by neuropsychological testing
Exclusion Criteria:
- History of neurological disease or injury
- History of severe mental illness
- Current untreated alcohol or substance abuse
- Other conditions may exclude; please discuss with contact
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Cognitively intact older adults - ACTIVE tDCS
Group receives active brain stimulation
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Active and/or sham; All participants receive both stimulation condition.
Groups will be counterbalanced (half receiving active tDCS in the first session and sham in the second session; the other half receiving the opposite).
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Aktiver Komparator: MCI ACTIVE tDCS
Group receives active brain stimulation
|
Active and/or sham; All participants receive both stimulation condition.
Groups will be counterbalanced (half receiving active tDCS in the first session and sham in the second session; the other half receiving the opposite).
|
Schein-Komparator: Cognitively intact older adults - SHAM tDCS
Group receives sham brain stimulation
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Active and/or sham; All participants receive both stimulation condition.
Groups will be counterbalanced (half receiving active tDCS in the first session and sham in the second session; the other half receiving the opposite).
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Schein-Komparator: MCI SHAM tDCS
Group receives sham brain stimulation
|
Active and/or sham; All participants receive both stimulation condition.
Groups will be counterbalanced (half receiving active tDCS in the first session and sham in the second session; the other half receiving the opposite).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Accuracy in Centimeters From Target Location for Allocentric
Zeitfenster: Outcome assessed after each of 2 sessions (estimated within 1 week of each other)
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1 active tDCS; 1 sham tDCS for each measure.
Participants touched a screen (using a ELO 19" touchscreen monitor) to document the location of the landmark.
The distance between the actual vs. selected location served as the dependent measure.
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Outcome assessed after each of 2 sessions (estimated within 1 week of each other)
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Hippocampal BOLD Signal During Task-based fMRI
Zeitfenster: change between active and sham tDCS sessions (<1month)
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BOLD signal change comparing active to sham tDCS during Allocentric navigation (i.e., active HD-tDCS > sham HD-tDCS).
Activation maps thresholded at p<.01 with minimum cluster size of 5 voxels.
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change between active and sham tDCS sessions (<1month)
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Dorsal Attention Network Connectivity During Resting-state fMRI
Zeitfenster: change between active and sham tDCS sessions (<1month)
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Change in resting state functional connectivity strength between active and sham tDCS sessions.
Strength is measured by Pearson r correlations between nodes, which are z-transformed, and summated.
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change between active and sham tDCS sessions (<1month)
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Egocentric
Zeitfenster: Outcome assessed after each of the 2 sessions
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Number of turns correctly recalled for each egocentric environment
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Outcome assessed after each of the 2 sessions
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Benjamin M Hampstead, PhD, VA Ann Arbor Healthcare System, Ann Arbor, MI
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- England HB, Fyock C, Meredith Gillis M, Hampstead BM. Transcranial direct current stimulation modulates spatial memory in cognitively intact adults. Behav Brain Res. 2015 Apr 15;283:191-5. doi: 10.1016/j.bbr.2015.01.044. Epub 2015 Jan 31.
- Lengu K, Ryan S, Peltier SJ, Tyszkowski T, Kairys A, Giordani B, Hampstead BM. Effects of High Definition-Transcranial Direct Current Stimulation on Local GABA and Glutamate Levels Among Older Adults with and without Mild Cognitive Impairment: An Exploratory Study. J Alzheimers Dis. 2021;84(3):1091-1102. doi: 10.3233/JAD-201091.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- C1381-P
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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