Repetitive Transcranial Magnetic Stimulation (rTMS) as a Cognitive Rehabilitation Approach for Veterans with Parkinson's Disease and Mild Cognitive Impairment: Protocol for a Randomized Sham-Controlled Trial (Preprint)
Notice bibliographique
Résumé
BACKGROUND: Parkinson disease (PD) is characterized by motor symptoms as well as progressive cognitive decline leading to long-term functional impairment and diminished quality of life. Mild cognitive impairment in PD (PD-MCI) is a risk factor for developing PD-related dementia. PD-MCI provides a window to assess interventions that can improve cognition. Repetitive transcranial magnetic stimulation (rTMS) shows promise as an effective treatment to improve cognitive performance. OBJECTIVE: This study aims to test the safety and feasibility of a 10-session, high-frequency rTMS protocol applied to the left dorsolateral prefrontal cortex and the rTMS efficacy in improving cognitive test performance among veterans with PD-MCI. METHODS: This is a double-blind randomized controlled trial. We will enroll US military veterans with PD-MCI. Participants will be randomized to either active or sham rTMS treatment groups, each with 10 treatment sessions (2 sessions/day). Treatment need not be consecutive; rather, they can be spread across approximately 10 days (eg, Monday, Wednesday, Thursday, Monday, Tuesday, and Wednesday). Participants randomized to active rTMS will receive stimulation applied to the left dorsolateral prefrontal cortex at 110% the resting motor threshold, a 15-Hz rate, 5 seconds per train of pulses, a 10-second intertrial interval, and 40 trains of pulses per session. Each patient will receive approximately 3000 pulses per session. Sham stimulation will be administered at the same parameters as real rTMS; however, no magnetic field will be produced on the placebo side of the active or placebo coil. This protocol was approved by the Edward Hines Jr Veterans Administration Hospital and Jesse Brown Department of Veterans Affairs Medical Center institutional review boards. This study includes a Food and Drug Administration investigational device exemption (G190076). RESULTS: Safety will be assessed using the number of research-related adverse events experienced by the active rTMS group compared to the sham rTMS group. Feasibility will be assessed using protocol completion rates. To examine preliminary effects of rTMS, participants will complete a standardized neurocognitive battery assessment at baseline, end point, and 1-month follow-up. The primary study outcome is the change in score from baseline to end point on the National Institutes of Health-sponsored Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research Executive Composite score. This project was funded in June 2019, with additional funding secured in April 2024. As of April 2025, a total of 18 veterans with PD-MCI have completed the randomized controlled trial phase. Data collection is ongoing and will be completed by March 2027. We expect the results of this study to be available by March 2028. CONCLUSIONS: The knowledge gained on the safety, feasibility, and efficacy of rTMS will set the stage for future research optimizing therapeutic gains for existing cognitive rehabilitation treatments or developing new and adjunct treatments for PD-MCI. TRIAL REGISTRATION: ClinicalTrials.gov NCT03836950; https://clinicaltrials.gov/study/NCT03836950. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/77241.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,009 | 0,008 |
| Méta-épidémiologie (sens strict) | 0,007 | 0,003 |
| Méta-épidémiologie (sens large) | 0,007 | 0,003 |
| Bibliométrie | 0,003 | 0,002 |
| Études des sciences et des technologies | 0,003 | 0,003 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,002 | 0,001 |
| Intégrité de la recherche | 0,006 | 0,006 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,043 | 0,007 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».