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Stimulation pour améliorer la mémoire (STIM)

29 juin 2026 mis à jour par: Benjamin Hampstead, PhD, University of Michigan

Test de la stimulation transcrânienne à courant continu haute définition (HD-tDCS) comme traitement des troubles cognitifs légers

Cette étude testera les effets de différentes doses d'une forme de stimulation cérébrale non invasive pour le traitement des personnes atteintes de troubles cognitifs légers (MCI) et de démence de type Alzheimer (DAT).

Aperçu de l'étude

Description détaillée

Cette étude de recherche est menée pour obtenir des informations importantes sur les effets d'une stimulation électrique faible sur le fonctionnement du cerveau chez les personnes atteintes de troubles cognitifs légers (MCI) et de démence de type Alzheimer (DAT). Les résultats aideront à déterminer « combien » de stimulation est nécessaire pour améliorer la mémoire et les capacités de réflexion, comment cela affecte le fonctionnement du cerveau et qui est le plus susceptible d'en bénéficier. En fin de compte, ces informations peuvent guider les efforts de traitement pour les personnes à différents stades de la maladie d'Alzheimer. L'étude utilisera l'imagerie cérébrale pour voir si ces traitements modifient la façon dont les participants apprennent et se souviennent des informations. L'imagerie par résonance magnétique fonctionnelle (IRMf) et la tomographie par émission de positrons (TEP) seront utilisées. L'étude utilisera également des tests cognitifs et des questionnaires pour examiner si la mémoire des participants (et les capacités associées) changent en raison du traitement. L'étude recrutera des participants avec un diagnostic de MCI ou DAT. Il est prévu, mais pas obligatoire, que les participants soient co-inscrits au projet sur la mémoire et le vieillissement de l'Université du Michigan (UM-MAP ; HUM00000382).

Type d'étude

Interventionnel

Inscription (Réel)

233

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48105
        • University of Michigan

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

55 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

La description

Critère d'intégration:

  1. Diagnostic de déficience cognitive légère (MCI) ou de démence de type Alzheimer (DAT)
  2. Doit être compatible avec l'IRM, critères qui s'appliquent également à la stimulation transcrânienne à courant continu haute définition (HD-tDCS ; par exemple, absence d'implants métalliques ou électroniques dans le haut du corps ou la tête)
  3. Stable sur les médicaments pertinents pendant au moins 4 semaines avant l'inscription à l'étude

Critère d'exclusion:

  1. Certaines maladies neurologiques
  2. Certaines conditions psychiatriques
  3. Déficience sensorielle sévère

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur factice: Stimulation factice
Dose factice (placebo) de traitement HD-tDCS pendant 30 minutes, pendant 5 à 30 séances.
Les participants recevront un simulacre de HD-tDCS (placebo) pendant 30 minutes, pendant 5 à 30 sessions.
Expérimental: Stimulation de dosage 1 mA
1 dose de milliAmp de traitement HD-tDCS pendant 30 minutes, entre 5 et 30 séances.
Les participants recevront HD-tDCS à 1 mA pendant 30 minutes, pour 5 à 30 sessions.
Expérimental: Stimulation de dosage 2 mA
Dose de 2 milliampères de traitement HD-tDCS pendant 30 minutes, pour entre 5 et 30 séances.
Les participants recevront HD-tDCS à 2 mA pendant 30 minutes, pour entre 5 et 30 sessions.
Expérimental: Stimulation de dosage 3 mA
Dose de 3 milliampères de traitement HD-tDCS pendant 30 minutes, pour entre 5 et 30 séances.
Les participants recevront HD-tDCS à 3 mA pendant 30 minutes, pour entre 5 et 30 sessions.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Lateral Temporal Cortex Connectivity
Délai: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Primary outcome focuses on default mode network (DMN) between-network functional connectivity because the lateral temporal cortex is a core component of the DMN. Between-network functional connectivity is estimated from fMRI data as strength of temporal coupling between the DMN and other high-level (association) brain networks. For each participant and time point, correlation-based connectivity (Pearson r; Fisher r-to-z transformed; arbitrary units) computed between DMN regions and other regions of the association cortex defined using standard functional atlas. Higher values reflect stronger functional connectivity between DMN and other regions. A Z-score's range is infinite. Expected value is between -3 to 3. Analyses conducted separately for amyloid negative (A-) and amyloid positive (A+) participants. Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Self-Report of Contentment With Memory
Délai: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

The Multifactorial Memory Questionnaire (MMQ) consists of three scales measuring separate aspects of metamemory. Items are rated on a 5-point Likert scale (0-4) based on the test taker's experiences over the previous two weeks.

MMQ-Satisfaction (formerly called MMQ-Contentment) scale measures satisfaction, concern, and overall appraisal of one's own memory. Each of 18 statements is rated based on degree of agreement. The score range is 0 to 72, with higher scores indicating a higher degree of satisfaction.

Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Self-Report of Memory Mistakes
Délai: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Multifactorial Memory Questionnaire (MMQ) Ability Score - This scale measures self-perception of everyday memory ability. Respondents rate how often they experienced each of 20 common memory mistakes over the previous two weeks. The score range is 0 to 80, with higher scores indicating better self-reported memory ability.

Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Self-Report of Memory Strategies Used
Délai: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Multifactorial Memory Questionnaire (MMQ) Strategies Score - This scale measures the use of practical memory strategies and aids in day-to-day life. Respondents rate how often they used each of 19 memory strategies over the previous two weeks. The score range is 0 to 76, with higher scores indicating greater use of memory strategies.

Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Change in Memory Functioning
Délai: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
The Repeatable Battery of the Assessment of Neuropsychological Status (RBANS) is a comprehensive neuropsychological battery for the evaluation of global cognition. The delayed memory section is a measure of delayed recall and recognition for verbal and visual information. It includes the subtests List Recall, List Recognition, Story Memory, and Figure Recall. Low scores on this index indicate difficulties with recognition and retrieval of information from long-term memory stores This index is composed of both auditory and visual measures; therefore, a severe deficit in language, auditory processing, or visual functioning may impact one of the measures more than the other. Analysis included the sum of the raw scores for each of the delayed memory subtests, with possible scores ranging from 0 to 62. Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Change in Overall Fluid Cognitive Abilities
Délai: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Cognitive function was determined using the NIH Toolbox-Cognition Battery computerized tests, specifically the Fluid composite score. It is derived by averaging the subtests in the Fluid domain to achieve an overall standard score. Fully Corrected T-scores are adjusted for for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in the NIH Toolbox nationally representative normative sampling. The T-score has a mean of 50 in the general population and a SD of 10. Scores higher than the mean indicate better performance.

Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Cumulative Working Memory Effects of HD-tDCS Across Treatment Sessions
Délai: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

The n-back test is a working memory task where participants identify stimulus that matches stimulus experienced "n" steps back. Participants performed a 2-back test, in which they were asked to remember and press a button when shown a stimulus that appeared 2 steps before the current one (e.g. square, circle, square).

The number of correct and incorrect identifications are normalized (z-score). Total score is the z-score of correct button presses minus the z-score of incorrect button presses. A higher score (d') reflects better working memory performance. Possible scores range from -4.85 to 4.85. Positive change (increase) in 2-back score across treatment sessions indicates improvement in working memory performance. Data is shown as the mean slope calculation of participants across first 5 days of treatment and across all treatments, x=days of treatment, y=n-back score.

Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Cumulative Memory Accuracy Effects of HD-tDCS Across Treatment Sessions
Délai: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Paired Associates task is a verbal memory task that asks participants to learn a list of word pairs. After a delay, participants are shown correct and mismatched word pairs one at a time and asked to identify if the displayed word pair was from the list they were asked to learn or not.

Total accuracy is a proportion (total correct responses divided by total trials completed) ranging from 0 to 1 that measures the accuracy of a participant's responses to both correct and mismatched word pairs. Higher scores indicate better verbal memory performance, and positive changes over time indicate an improvement in verbal memory performance, measured after baseline (Session 1) and every intervention session (Sessions 2-5)

Data is shown as the mean slope calculation of participants across first 5 days of treatment and across all treatments, x=days of treatment, y= total accuracy.

Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Cumulative Memory Sensitivity Effects of HD-tDCS Across Daily Sessions
Délai: Baseline
Verbal memory performance for computerized Paired Associates task, summarized with a computational model (linear ballistic accumulator decision model). The model uses each participant's accuracy and reaction times across trials to estimate how efficiently they accumulate information to distinguish previously studied (target) word pairs from new (lure) pairs. Reported outcome is the average memory sensitivity score at baseline, expressed as unitless model values (scores on a scale) where higher scores indicate better discrimination, scores near zero indicate chance-level performance, and negative scores (if present) indicate performance worse than chance.
Baseline
Tolerability of HD-tDCS
Délai: Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks); values represent mean symptom burden averaged across all post-stimulation assessments
Tolerability was assessed using the HD-tDCS Safety Questionnaire, an 11-item symptom checklist. The questionnaire assesses the presence (yes/no) of 10 specific self-reported symptoms (Itching, Burning, Tingling, Scalp Pain, Trouble Concentrating, Sleep problems, Headache, Mood Change, Neck Pain, and Other symptoms) and 1 oberserved symptom, Skin Redness. Skin Redness was excluded from this analysis as it is not related to the participant's perception of tolerability. The total score (symptom burden) was calculated by summing the number of symptoms present across the 10 items for each session. Score range: 0 to 10 symptoms, where 0 = no symptoms present and 10 = all symptoms present. Higher scores indicate worse tolerability (more symptoms experienced). Values represent the mean number of symptoms per session, calculated by averaging symptom burden scores across all post-stimulation assessments within each treatment group.
Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks); values represent mean symptom burden averaged across all post-stimulation assessments
Effectiveness of Blinding of HD-tDCS
Délai: Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks)
Participant's perception of treatment assignment assessed after each stimulation session using a 3-category ordinal scale. Participants guessed whether they received: (0) Sham stimulation, (1) Don't Know, or (2) Active stimulation. The scale is ordinal with Sham < Don't Know < Active. Effective blinding is indicated by no significant difference in the distribution of perceived assignment between active and sham groups (i.e., participants in active groups cannot reliably distinguish their treatment from sham). Higher proportional odds ratios would indicate active group participants were more likely to guess "active"; lower ratios would indicate sham participants were more likely to guess "active" (paradoxical pattern suggesting convincing sham condition).
Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks)
Change in Default Mode Network Connectivity
Délai: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

The outcome focuses on default mode network (DMN) within-network functional connectivity. Within-network functional connectivity is estimated from fMRI data as strength of temporal coupling within DMN regions (nodes). For each participant and time point, correlation-based connectivity (Pearson r; Fisher r-to-z transformed; arbitrary units) was computed between DMN regions defined using a standard functional atlas. Higher values reflect stronger functional connectivity within DMN. A Z-score's range is infinite. Expected value is around -3 to 3. Analyses are conducted separately for amyloid negative (A-) and amyloid positive (A+) participants.

Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Cumulative Cognitive Change Across Daily Consecutive Sessions
Délai: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Measured through change in Cogstate or other comparable computerized cognitive testing scores across consecutive daily sessions.
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Change in Global Cognition
Délai: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

The Repeatable Battery of the Assessment of Neuropsychological Status (RBANS) is a comprehensive neuropsychological battery for the evaluation of global cognition and has been validated in subjects with mild cognitive impairment, moderate to severe traumatic brain injuries, vascular dementias, and Alzheimer's disease. Data was analyzed using the sum of the subtest raw scores, which is an indicator of the general cognitive functioning of the examinee. Low scores suggest general cognitive impairment even when some individual subtest scores may be within normal limits. Individuals with low scores on this measure exhibit problems with attention, memory, language, and construction skills. Possible scores range from 0 to 321.

Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Modification de la capacité d'inhibition
Délai: Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Intention a priori de mesurer par le biais d'un changement dans le NIH Toolbox Flanker Inhibitory Control and Attention Test Score
Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Changement dans la capacité de conceptualisation
Délai: Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Intention a priori de mesurer à travers le changement dans le score du test de tri des cartes de changement dimensionnel de la boîte à outils des NIH
Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Modification de la mémoire de séquence d'images
Délai: Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Intention a priori de mesurer en modifiant le score du test de mémoire de séquence d'images de la boîte à outils NIH
Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Modification de la capacité de mémoire de travail
Délai: Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Intention a priori de mesurer en modifiant le résultat du test de mémoire de travail de tri de la liste de la boîte à outils des NIH
Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Modification de la vitesse de traitement
Délai: Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Intention a priori de mesurer en modifiant le score du test de vitesse de traitement de la comparaison des modèles de la boîte à outils NIH
Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Modification du fonctionnement visuospatial
Délai: Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Mesuré par l'évolution du score de l'indice visuospatial RBANS
Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Changement dans le fonctionnement du langage
Délai: Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Mesuré par l'évolution du score de l'indice de langue RBANS
Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Changement d'attention
Délai: Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Mesuré par l'évolution du score de l'indice d'attention RBANS
Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Modification du fonctionnement de la mémoire
Délai: Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Mesuré par le changement du score de l'indice de mémoire immédiate RBANS
Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Modification du fonctionnement cognitif
Délai: Ligne de base et post-intervention (après les sessions tDCS 5 et 30)
Intention a priori de mesurer à travers les changements dans les scores des sous-tests RBANS
Ligne de base et post-intervention (après les sessions tDCS 5 et 30)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Benjamin Hampstead, PhD, Associate professor

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 avril 2019

Achèvement primaire (Réel)

6 décembre 2024

Achèvement de l'étude (Réel)

19 décembre 2024

Dates d'inscription aux études

Première soumission

11 mars 2019

Première soumission répondant aux critères de contrôle qualité

13 mars 2019

Première publication (Réel)

14 mars 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • HUM00146180
  • 1R01AG058724 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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