Brain-Oscillation Synchronized Stimulation of the DMPFC
Obsessive Compulsive Disorder (OCD) · Treatment Resistant Obsessive Compulsive Disorder
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 65 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 48 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
This trial aims to obtain initial evidence about the clinical efficacy and modulation of neurophysiological markers in obsessive compulsive disorder (OCD) using personalized (i.e., electroencephalography (EEG)-triggered) repetitive transcranial magnetic stimulation (rTMS) as compared to non-personalized (i.e., non-EEG triggered), standard rTMS applied to the dorsomedial prefrontal cortex.
Leer la descripción completa
This trial uses a prospective, randomized, single-blind study design with two treatment arms at the Centre for Addiction and Mental Health (CAMH) in Toronto, ON, Canada. The study aims to compare the clinical effects of EEG-triggered, personalized rTMS (i.e., experimental arm) in the treatment of OCD to those of non-EEG triggered, non-personalized rTMS (i.e., active-comparator arm). Additionally, the study aims to compare the modulation of neurophysiological (i.e., EEG) markers of OCD between the two arms.
Study treatment will be administered five days per week across a six-week treatment course for a total of 30 sessions. Both rTMS arms will use the same TMS coil, stimulation intensity, number of pulses, and anatomical target (i.e., dorsomedial prefrontal cortex).
Clinical outcomes will be measured using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) with clinical response defined as a ≥30% improvement on the Y-BOCS. The self-reported revised Obsessive Compulsive Inventory (OCI-R) and Clinical Global Impressions - Improvement (CGI-I) scale will also be used. Neurophysiological outcomes will be measured by the change in frontoparietal theta amplitude (i.e., 4-7 Hz) and power of TMS-induced theta oscillations.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
1. Are 18-65 years old;
2. Have OCD as a primary disorder, confirmed by a MINI diagnosis of OCD;
3. Have OCD with treatment resistance as defined by failure of at least a course of cognitive-behavioural therapy or a single trial (≥4 weeks) of an SSRI;
4. Does not meet criteria for substance use disorder as determined by the MINI (with the exception of nicotine and caffeine);
5. Have a Y-BOCS score ≥20;
6. Are fluent in the English language (spoken, written and reading);
7. Have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
8. Must be deemed to have capacity to provide informed consent;
9. Must sign and date the informed consent form;
10. Stated willingness to comply with all study procedures.
Exclusion Criteria:
1. Have any contraindications to TMS as determined by the TASS questionnaire (18);
2. Have a history of a medical or neurological disorder that affects CNS (such as, traumatic brain injury, stroke, Parkinson);
3. Are pregnant or breast feeding. TMS is not unsafe in pregnancy and therefore we are not requiring a pregnancy test prior to entry. If patients become pregnant during the study they will not be excluded. We are not including patients who are currently aware of being pregnant as OCD can be affected during the later stages of pregnancy and therefore is a potential confound;
4. Have history of seizures;
5. Have any metal implant or dentures;
6. Have serious or unstable medical condition requiring immediate investigation or treatment (e.g. severe or recent cardiac disease);
7. Have cardiac pacemaker, cochlear implants, implanted electronic devices or non- electronic metallic implants or other contraindications for TMS;
8. Taking more than 2mg of lorazepam or equivalent benzodiazepine, or any anticonvulsant medication;
9. Fulfill MINI criteria for Alcohol Use Disorder;
10. Have received any ablative neurological procedure (e.g., focused ultrasound).
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento doble
Personalized, EEG-triggered rTMS
No informado en este registro.
Device: EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS)
Non-personalized, non-EEG triggered rTMS
No informado en este registro.
Device: Non-EEG Triggered Repetitive Transcranial Magnetic Stimulation (rTMS)
EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE
The rTMS intervention will be delivered using the MagPro XP - Orange Edition stimulator and COOL D-B80 coil to the dorsomedial prefrontal cortex 4 cm anterior to the foot hotspot. EEG data will be analyzed in real-time using the bossdevice MEDICAL and TMS pulses will be synchronized to the negative peak of the frontoparietal theta oscillation.
500 consecutive EEG theta-oscillation negative-peak triggered quadruplet bursts with a 5ms inter-pulse-interval will be applied at a median inter-burst interval of 2-3s. The therapeutic intervention consists of 30 sessions of 2000 TMS pulses each for a total duration per treatment session of 15-30 minutes.
Non-EEG Triggered Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE
The rTMS intervention will be delivered using the MagPro XP - Orange Edition stimulator and COOL D-B80 coil to the dorsomedial prefrontal cortex 4 cm anterior to the foot hotspot.
High-frequency rTMS consisting of 50 trains at 20 Hz (2s on, 18s off) will be delivered. The therapeutic intervention consists of 30 sessions of 2000 TMS pulses each for a total duration per treatment session of 15-30 minutes.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Plazo: From screening to the end of the follow-up period (1-month post-intervention)
The Y-BOCS is used to (a) qualify OCD symptoms using a symptom checklist and (b) assess their severity using a symptom severity rating scale. The checklist allows the participant to identify the thoughts and behaviours that are part of their OCD. The severity scale assesses five dimensions of obsessions and compulsions: time spent or occupied, interference with functioning or relationships, degree of distress, resistance, and control (i.e., success with resistance). The scale ranges from 0-40; a lower score indicates less severe OCD, while a higher score indicates more severe OCD.
Medidas secundarias
Obsessive Compulsive Inventory - Revised (OCI-R)
Plazo: From screening to the end of the follow-up period (1-month post-intervention)
The OCI-R is a self-reported 18-item scale that measures symptom severity across six domains of OCD: washing, checking, ordering, neutralizing, obsessing, and hoarding. The scale ranges from 0-72; lower scores indicate less severe OCD (or a subclinical presentation for scores \<21), while higher scores indicate more severe OCD.
Clinical Global Impressions - Improvement (CGI-I) Scale
Plazo: From screening to the end of the follow-up period (1-month post-intervention)
The CGI-I is a clinician-determined assessment that rates change in global clinical presentation (i.e., improvement or worsening) from the baseline presentation on a 7-point scale.
Electroencephalography (EEG) Markers of OCD
Plazo: From screening to the end of the follow-up period (1-week post-intervention)
1. Amplitude of frontoparietal theta oscillations in the resting EEG before and after single treatment sessions measured in dB
2. the power of TMS-induced oscillations in the theta range throughout the six-week treatment course measured in dB
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Centre for Addiction and Mental HealthToronto, Ontario, CanadaReclutando
Equipo y fechas
- Patrocinador principal
- Centre for Addiction and Mental Health
- Inicio del estudio
- 29 ene 2025 Real
- Finalización primaria
- 2029-01 Estimado
- Finalización del estudio
- 2029-01 Estimado
- Primera publicación
- 24 abr 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Brain-Oscillation Synchronized Stimulation of the DMPFC: A Single-Blind Study for Personalized Neuromodulation in OCD
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026