Electrophysiological Biomarkers and Treatment Response to Accelerated Transcranial Magnetic Stimulation in Patients With Obsessive-Compulsive Disorder (TMS-OCD-EEG)
Investigation of the Relationship Between Electrophysiological Biomarkers and Treatment Response in Patients Diagnosed With Obsessive-Compulsive Disorder Undergoing Transcranial Magnetic Stimulation Therapy
Purpose:
This study aims to evaluate the effectiveness of an accelerated intermittent Theta Burst Stimulation (iTBS) protocol-a non-invasive brain stimulation technique-targeted at the dorsomedial prefrontal cortex (dmPFC) and anterior cingulate cortex (ACC) in patients with treatment-resistant Obsessive-Compulsive Disorder (OCD). Additionally, the study seeks to identify electrophysiological biomarkers (such as EEG microstates and heart rate variability) that may predict which patients are most likely to benefit from the treatment.
Methodology:
The study will include 30 patients aged 18-65 diagnosed with OCD according to DSM-5 criteria who have not responded sufficiently to standard treatments. Participants will undergo an intensive 7-day treatment program consisting of 4 iTBS sessions per day (totaling 28 sessions). Clinical symptoms will be assessed before and after the treatment using standardized scales, including the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Hamilton Depression Rating Scale (HAM-D), and Hamilton Anxiety Rating Scale (HAM-A). Resting-state EEG measurements and heart rate data will be recorded during and after the sessions to analyze physiological changes.
Goal:
The findings are expected to contribute to the development of personalized neuromodulation protocols and help identify predictors of treatment response for OCD patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sarp Yoldas, MD
- Número de teléfono: +905069898506
- Correo electrónico: sarpyoldas@gmail.com
Ubicaciones de estudio
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Bakirkoy
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Istanbul, Bakirkoy, Turquía (Türkiye), 34153
- Reclutamiento
- Cerrahpaşa Tıp Fakültesi Prof. Dr. Murat Dilmener Hastanesi
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Contacto:
- Sarp Yoldas, MD
- Número de teléfono: +905069898506
- Correo electrónico: sarpyoldas@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Being between 18 and 65 years of age.
- Being diagnosed with Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria.
- Non-responsiveness to at least one Selective Serotonin Reuptake Inhibitor (SSRI) treatment at an adequate dose and duration.
- Having a Y-BOCS score of ≥20 following the initial evaluation.
- No change in the current medications within the last 2 months and a commitment to maintaining stable doses throughout the study.
- Providing informed consent and having no contraindications for TMS.
Exclusion Criteria:
- Severe neurological disorders or neurodegenerative diseases.
- Any condition associated with increased seizure risk
- History of cochlear implants, metal implants in the head and neck area, cardiac pacemakers, deep brain stimulation, or vagus nerve stimulation.
- History of neurosurgical intervention.
- General contraindications for Transcranial Magnetic Stimulation therapy.
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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Comparador activo: TMS Treatment Arm
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Accelerated intermittent Theta Burst Stimulation (iTBS) will be delivered using a MagVenture MagPro R30 stimulator with a Cool D-B80 double cone coil. The stimulation is targeted at the dorsomedial prefrontal cortex (dmPFC) and anterior cingulate cortex (ACC), specifically 25.8% anterior of the nasion-inion distance. The treatment will be applied at 100% of the motor threshold, which is determined via the Extensor Hallucis Longus muscle. The protocol consists of an intensive 7-day program with 4 sessions per day, totaling 28 sessions. Each session delivers 1,800 pulses and lasts approximately 9 minutes. Patients will continue their stable dose of Selective Serotonin Reuptake Inhibitors (SSRIs) throughout the study. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score
Periodo de tiempo: Change from baseline in clinical scales at the end of the 7-day treatment and at follow-up points (1, 3, and 6 months post-treatment)"
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The Y-BOCS is a 10-item clinician-administered scale used to assess the severity of obsessive-compulsive symptoms.
Each item is rated from 0 to 4. The total score ranges from 0 to 40, where higher scores indicate greater symptom severity (32-40: extreme, 24-31: severe, 16-23: moderate, 8-15: mild, 0-7: subclinical).
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Change from baseline in clinical scales at the end of the 7-day treatment and at follow-up points (1, 3, and 6 months post-treatment)"
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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EEG Microstate Analysis Parameters
Periodo de tiempo: Baseline, Day 7 (after treatment)
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Resting-state EEG data will be analyzed using the MICROSTATELAB v2.1 extension for EEGLAB focusing on the four canonical microstate classes labeled A, B, C, and D. For each participant, four specific spatio-temporal parameters will be calculated to evaluate neural dynamics.
These include Mean Duration which measures the average lifespan of a specific microstate in milliseconds to represent the stability of neural generators, and Occurrence which measures the average frequency of each microstate per second in Hz to reflect activation tendencies.
Additionally, Time Coverage will be calculated as the percentage of total analysis time during which a specific class is dominant, and Transition Probability will be determined to show the likelihood of one microstate class transitioning into another, providing insight into the sequential activation dynamics of the underlying neural networks.
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Baseline, Day 7 (after treatment)
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Frontal-Vagal Activity via Heart Rate Deceleration (HRD)
Periodo de tiempo: During each of the 28 iTBS sessions over the 7-day treatment period
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Heart rate data will be recorded using a Polar H10 sensor during iTBS sessions.
HRD will be calculated as the change in heart rate (beats per minute - bpm) during the stimulation period compared to the pre-stimulation baseline.
Lower heart rate (greater deceleration) is investigated as a predictor of higher fronto-vagal activation and treatment response.
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During each of the 28 iTBS sessions over the 7-day treatment period
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1395891
- 38661 (Otro número de subvención/financiamiento: İstanbul Üniversitesi-Cerrahpaşa Rektörlüğü, Bilimsel Araştırma Projeleri)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
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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Ensayos clínicos sobre EEG
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Ensayos clínicos sobre iTBS TMS
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