- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07701785
Superior Parietal iTBS for PD-MCI
Accelerated Intermittent Theta Burst Stimulation for Mild Cognitive Impairment in Parkinson's Disease
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Reclutamiento
- Medical University of South Carolina
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Contacto:
- Sam Crowley, PhD
- Número de teléfono: 843-792-7767
- Correo electrónico: crowleys@musc.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 50-85 years of age
- Diagnosis of Parkinson's disease based on UK Brain Bank diagnostic criteria
- Parkinson's disease with mild cognitive impairment (PD-MCI) diagnosis per Movement Disorders Society Task Force Level II Diagnostic Criteria4 (i.e., scores ≥1.5 standard deviations below appropriate norms on 2 neuropsychological tests) as determined by a clinical neuropsychologist
- Stable on Parkinson's disease medications for 30 days (not expected to change through the course of the treatment)
- Has a caregiver willing and able to reliably complete a questionnaire focused on the participant's daily functioning
Exclusion Criteria:
- Claustrophobia or inability to lie supine in the scanner for an extended period of time
- Barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)
- Contraindications to MRI/TMS safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, non-removable hair clips or piercings, and medications that reduce seizure threshold.
- Individuals with a diagnosis of bipolar disorder, schizophrenia, and/or active substance abuse disorder.
- History of significant or unstable condition/s or treatments for these condition/s that may impact cognition (as determined by the study investigators) such as significant cardiac (e.g. heart failure), infectious (e.g. HIV, urinary tract infection), or metabolic disease (e.g. labile diabetes), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. multiple sclerosis, moderate to severe brain injury, seizures).
- History of a seizure disorder.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Accelerated iTBS
Participants will undergo accelerated intermittent theta burst stimulation (iTBS) targeting the right superior parietal lobule (rSPL) using a MagVenture MagPro system with a cooled butterfly coil, with Brainsight neuronavigation identifying the stimulation site.
Resting motor threshold (rMT) will be determined on the first stimulation visit using Parameter Estimation by Sequential Testing (PEST).
Stimulation for the intervention will be delivered at 120% rMT.
Stimulation sessions will occur over three consecutive days.
Each day will include 10 sessions separated by 10-15 min.
Each session delivers 600 pulses (50 Hz triplets; 2 s on/8 s off; ~190 seconds), totaling 6,000 pulses/day and 18,000 pulses overall.
Coil position/angle and scalp-to-cortex distance are tracked; tolerability/acceptability (headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) will be assessed before and after sessions.
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Participants in this single-arm study will receive a accelerated course of intermittent theta burst stimulation (iTBS) over superior parietal lobule, which is identified with MNI coordinates from past studies. The stimulation will be delivered using a MagVenture MagPro TMS System with a butterfly, active cooling coil at 120% of resting motor threshold. Each participant will complete 3 consecutive treatment days, undergoing10 rTMS sessions per day (600 pulses/session), totaling 18,000 pulses across the study. Safety, tolerability, adherence, and feasibility data will be collected for the intervention. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serious Adverse Events
Periodo de tiempo: Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
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Number of serious adverse events experienced by study participants caused by the iTBS protocol
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Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
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Feasibility of the study protocol
Periodo de tiempo: Week 0 through completion of study (8 weeks)
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Feasibility will be defined as the proportion of participants enrolled that complete all intervention procedures
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Week 0 through completion of study (8 weeks)
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Tolerability of TMS procedures
Periodo de tiempo: Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
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A questionnaire evaluating the presence and severity of commonly experienced side effects of TMS (i.e.
headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) within the past 24 hours and during stimulation.
Ratings will be on a 6-point Likert scale from 0 (no symptoms) to 5 (severe symptoms).
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Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3
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Test-retest reliability of the Continuous Temporal Expectancy Test (CTET)
Periodo de tiempo: Week 0 (4 weeks pre-intervention) to Week 4, Day 1 (30 minutes prior to intervention)
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The CTET is a tablet-administered measure designed to assess sustained attention and distractibility.
Participants will be shown a grid with black and white squares on a tablet that rotate after either a longer duration (target stimulus; 1070ms) or a shorter duration (non-target stimulus; 800ms) and must press the screen when they identify a target stimulus.
Participants will complete 10 one-minute trials.
Half of the trials are performed without a distractor present, and the other half are performed with an audio-video distractor presented on an adjacent laptop screen.
The primary outcome is the distractibility score, defined as the difference in latency (in ms) to identifying the target stimulus between distractor and non-distractor trials.
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Week 0 (4 weeks pre-intervention) to Week 4, Day 1 (30 minutes prior to intervention)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Continuous Temporal Expectancy Task (CTET) Distractibility Score
Periodo de tiempo: Week 4, Day 1 (30 minutes prior to intervention) to Week 4, Day 3 (15 minutes after intervention) to Week 8 (4 weeks post-intervention)
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Change in CTET Distractibility Score ([distraction trial latency in ms] - [non-distraction trial latency in ms]).
Higher scores indicate worse performance.
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Week 4, Day 1 (30 minutes prior to intervention) to Week 4, Day 3 (15 minutes after intervention) to Week 8 (4 weeks post-intervention)
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Change in NIH Toolbox Cognitive Battery (NIHTB-CB) Composite Scores
Periodo de tiempo: Week 4, Day 1 (30 minutes prior to intervention intervention) to Week 4, Day 3 (15 minutes after intervention) to Week 8 (4 weeks post-intervention)
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The NIHTB-CB is a performance-based, iPad-administered suite of 7 tests that ascertain abilities in different cognitive domains (i.e.
executive function, episodic memory, working memory, processing speed, language).
It was developed using advanced psychometric techniques to minimize measurement error and produces normed subtest and composite scores.
We will use the fully-corrected T-score (range T=0-100; Mean T=50, SD=10; higher scores indicating better cognition) of the Fluid Cognition Composite and Crystallized Cognition Composite, which are normed for age, sex, years of education, and race/ethnicity.
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Week 4, Day 1 (30 minutes prior to intervention intervention) to Week 4, Day 3 (15 minutes after intervention) to Week 8 (4 weeks post-intervention)
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Change in daily functioning
Periodo de tiempo: Week 0 (1 month pre-intervention) to Week 8 (1 month post-intervention)
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Change in caregiver ratings on the ECog-12, a questionnaire designed to measure the participant's everyday cognition and functional decline based on 12 Likert scale items ranging from 1 (no change compared to 10 years earlier) to 4 (consistently much worse).
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Week 0 (1 month pre-intervention) to Week 8 (1 month post-intervention)
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Change in Beck Depression Inventory II (BDI-II) Raw Score
Periodo de tiempo: Week 4, Day 1 (pre-intervention) to Week 8 (1 month post-intervention)
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The Beck Depression Inventory II (BDI-II) is a self-report measure of depressive symptoms comprised of 21 questions rated on a Likert scale from 0 (least severe) to 3 (most severe).
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Week 4, Day 1 (pre-intervention) to Week 8 (1 month post-intervention)
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Change in Beck Anxiety Inventory (BAI) Score
Periodo de tiempo: Week 1, Day 1 (pre-intervention) to Week 8 (one-month follow-up)
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The Beck Anxiety Inventory (BAI) is a self-report measure of depressive symptoms comprised of 21 questions rated on a Likert scale from 0 (least severe) to 3 (most severe).
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Week 1, Day 1 (pre-intervention) to Week 8 (one-month follow-up)
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Change in Apathy Evaluation Scale (AES) Raw Score
Periodo de tiempo: Week 4, Day 1 (pre-intervention) to Week 8 (1-month post-intervention)
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The Apathy Evaluation Scale is a self-report measure of apathy symptoms comprised of 18 Likert scale items rated from 0 (least severe) to 3 (most severe).
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Week 4, Day 1 (pre-intervention) to Week 8 (1-month post-intervention)
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Sinucleinopatías
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Trastornos neurocognitivos
- Trastornos cognitivos
- Enfermedades neurodegenerativas
- Trastornos del movimiento
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Disfunción congnitiva
- Enfermedad de Parkinson
Otros números de identificación del estudio
- Pro00151225
- K12TR005297 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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