Hjerne-oscillasjon synkronisert stimulering av DMPFC (BOSS-OCD)
Hjerne-oscillasjonssynkronisert stimulering av DMPFC: en enkeltblind studie for personlig neuromodulering i OCD
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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ashley Melichercik, MSc
- Telefonnummer: 30899 416-535-8501
- E-post: ashley.melichercik@camh.ca
Studer Kontakt Backup
- Navn: Brigitte Zrenner, MD
- Telefonnummer: 34574 416-535-8501
- E-post: brigitte.zrenner@camh.ca
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M6J 1H1
- Rekruttering
- Centre for Addiction and Mental Health
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Ta kontakt med:
- Nina E. Bahl, MSc
- Telefonnummer: 30882 416-535-8501
- E-post: nina.bahl@camh.ca
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Hovedetterforsker:
- Brigitte Zrenner, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Are 18-65 years old;
- Have OCD as a primary disorder, confirmed by a MINI diagnosis of OCD;
- 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;
- Does not meet criteria for substance use disorder as determined by the MINI (with the exception of nicotine and caffeine);
- Have a Y-BOCS score ≥20;
- Are fluent in the English language (spoken, written and reading);
- Have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
- Must be deemed to have capacity to provide informed consent;
- Must sign and date the informed consent form;
- Stated willingness to comply with all study procedures.
Exclusion Criteria:
- Have any contraindications to TMS as determined by the TASS questionnaire (18);
- Have a history of a medical or neurological disorder that affects CNS (such as, traumatic brain injury, stroke, Parkinson);
- 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;
- Have history of seizures;
- Have any metal implant or dentures;
- Have serious or unstable medical condition requiring immediate investigation or treatment (e.g. severe or recent cardiac disease);
- Have cardiac pacemaker, cochlear implants, implanted electronic devices or non- electronic metallic implants or other contraindications for TMS;
- Taking more than 2mg of lorazepam or equivalent benzodiazepine, or any anticonvulsant medication;
- Fulfill MINI criteria for Alcohol Use Disorder;
- Have received any ablative neurological procedure (e.g., focused ultrasound).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Personlige, EEG-utløste RTMS
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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.
Andre navn:
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Aktiv komparator: Ikke-personalisert, ikke-EEG utløste RTMS
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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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Tidsramme: From screening to the end of the follow-up period (1-month post-intervention)
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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. |
From screening to the end of the follow-up period (1-month post-intervention)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Obsessive Compulsive Inventory - Revised (OCI-R)
Tidsramme: From screening to the end of the follow-up period (1-month post-intervention)
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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. |
From screening to the end of the follow-up period (1-month post-intervention)
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Clinical Global Impressions - Improvement (CGI-I) Scale
Tidsramme: From screening to the end of the follow-up period (1-month post-intervention)
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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. |
From screening to the end of the follow-up period (1-month post-intervention)
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Electroencephalography (EEG) Markers of OCD
Tidsramme: From screening to the end of the follow-up period (1-week post-intervention)
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From screening to the end of the follow-up period (1-week post-intervention)
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Brigitte Zrenner, MD, Centre for Addiction and Mental Health
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 104-2023
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
De-identified data from this project may be used for future research by internal and/or external project collaborators upon participant consent.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
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