ipRGC som en potensiell biomarkør for å predikere behandlingsrespons ved transkraniell magnetisk stimulering ved major depressiv lidelse (BRIGHT)
Belysning av depresjon: ipRGC som en potensiell biomarkør for å forutsi behandlingsrespons ved transkraniell magnetstimulering ved alvorlig depressiv lidelse
This research explores the potential of retinal ganglion cells (RGCs), particularly intrinsically photosensitive RGCs (ipRGCs), as biomarkers for predicting response to transcranial magnetic stimulation (TMS) in treatment-resistant depression (TRD). We also aim to assess the impact of TMS treatment on RGCs and ipRGCs in TRD patients, investigating associations with clinical improvements and cognitive status. A clinical trial involving 44 patients with treatment-resistant depression (TRD) will be conducted. All participants will receive rTMS targeting the dorsolateral prefrontal cortex (DLPFC). Data will be collected pre- and post-intervention, as well as at a 2-month follow-up, using multiple outcome measures, including the post-illumination pupil response (PIPR). The project seeks to confirm the effectiveness of TMS and the potential of RGCs/ipRGCs as predictors of treatment response, thereby facilitating the development of personalized treatment strategies for TRD patients undergoing rTMS therapy.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Inês Duarte D Pais, MSc
- Telefonnummer: +351 222 061 000
- E-post: idp@ess.ipp.pt
Studer Kontakt Backup
- Navn: Catarina C Mateus, PhD
- Telefonnummer: +351 222 061 000
- E-post: cms@ess.ipp.pt
Studiesteder
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Porto District
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Porto, Porto District, Portugal, 4200-072
- Rekruttering
- RISE-Health, Center for Translational Health and Medical Biotechnology Research (TBIO), School of Health, Polytechnic of Porto
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Ta kontakt med:
- Nuno B Rocha, PhD
- Telefonnummer: +351 913474780
- E-post: nrocha@ess.ipp.pt
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Deltakelseskriterier
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Beskrivelse
Inclusion Criteria:
- Diagnosis of MDD, confirmed via the structured clinical interview;
- TRD type;
- Age between 18-65 years;
- Visual acuity of 20/32 or better.
Exclusion Criteria:
- Prior rTMS treatment;
- Contraindications for TMS;
- Psychiatric disorders other than MDD;
- Systemic diseases affecting the eyes (e.g., diabetes mellitus);
- Ocular conditions;
- Head injuries causing loss of consciousness;
- Current or past alcohol/substance dependence within 6 months;
- Neurodegenerative diseases;
- Major neurological illnesses;
- Use of medications affecting iris mechanics or the autonomic nervous system.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: iTBS
iTBS Group (n=44) will receive high-frequency (50 Hz) left-side DLPFC iTBS (120% RMT stimulation intensity; 50 Hz frequency; 2s on and 8 s off; 600 pulses/session; total duration of 3 minutes). Treatment comprised 20 sessions in total, which consisted of once-daily sessions (on weekdays). |
Each participant's resting motor threshold (RMT) will be determined by visual observation in accordance with standard clinical practice. Intermittent theta-burst stimulation (iTBS) will be delivered over the left dorsolateral prefrontal cortex (DLPFC) using these parameters: stimulation intensity 120% RMT; bursts at 50 Hz; 2 s on and 8 s off; 600 pulses per session; total stimulation time approximately 3 minutes per session. Stimulation will be delivered using a MagPro X100 stimulator with MagOption, equipped with a B70 butterfly-shaped coil with static cooling (MagVenture, Denmark). Treatment will comprise 20 sessions, delivered once daily on weekdays.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Chromatic pupillometry
Tidsramme: Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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To extract post-illumination pupil response (PIPR) derived from ipRGCs |
Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Optical Coherence Tomography (OCT)
Tidsramme: Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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To extract central retinal thickness and thicknesses of retina neuronal layers (GCL-IPL and RNFL) |
Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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Pattern Electroretinogram (PERG)
Tidsramme: Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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To extract PERG N95 wave related to RGC function. |
Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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Contrast sensitivity test
Tidsramme: Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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To measure contrast sensitivity |
Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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Montgomery-Åsberg Depression Rating Scale (MADRS)
Tidsramme: Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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To evaluate treatment response. Scores range from 0 to 60, with higher scores indicating more severe depressive symptoms. |
Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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Maudsley Staging Depression
Tidsramme: Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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To assess the level of treatment resistance in depression. Scores range from 3 to 15, with higher scores indicating greater treatment resistance. |
Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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California Verbal Learning Test-II (CVLT-II)
Tidsramme: Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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To assess verbal learning and memory. Scores range from 0 to 80, with higher scores indicating better verbal learning and memory performance. |
Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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Reading Mind in Eyes Test (RMET)
Tidsramme: Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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To assess social cognition and theory of mind through recognition of mental states from images of the eye region. Scores range from 0 to 36, with higher scores indicating better social cognitive performance. |
Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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Symbol Digit Modalities Test (SDMT)
Tidsramme: Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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To assess information processing speed and attention. Scores range from 0 to 110, with higher scores indicating better cognitive processing speed performance. |
Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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Brief Visuospatial Memory Test-Revised (BVMT-R)
Tidsramme: Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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To assess visuospatial learning and memory. Scores range from 0 to 36, with higher scores indicating better visuospatial memory performance. |
Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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WHODAS 12-item (Self-report)
Tidsramme: Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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To assess disability and functional impairment in daily life. Scores range from 12 to 60, with higher scores indicating greater disability. |
Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Catarina C Mateus, PhD, Polytechnic Institute of Porto
Publikasjoner og nyttige lenker
Generelle publikasjoner
- De Risio L, Borgi M, Pettorruso M, Miuli A, Ottomana AM, Sociali A, Martinotti G, Nicolo G, Macri S, di Giannantonio M, Zoratto F. Recovering from depression with repetitive transcranial magnetic stimulation (rTMS): a systematic review and meta-analysis of preclinical studies. Transl Psychiatry. 2020 Nov 10;10(1):393. doi: 10.1038/s41398-020-01055-2.
- Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
- Laurenzo SA, Kardon R, Ledolter J, Poolman P, Schumacher AM, Potash JB, Full JM, Rice O, Ketcham A, Starkey C, Fiedorowicz JG. Pupillary response abnormalities in depressive disorders. Psychiatry Res. 2016 Dec 30;246:492-499. doi: 10.1016/j.psychres.2016.10.039. Epub 2016 Oct 21.
- Jung KI, Hong SY, Shin DY, Lee NY, Kim TS, Park CK. Attenuated Visual Function in Patients with Major Depressive Disorder. J Clin Med. 2020 Jun 22;9(6):1951. doi: 10.3390/jcm9061951.
- Kalenderoglu A, Celik M, Sevgi-Karadag A, Egilmez OB. Optic coherence tomography shows inflammation and degeneration in major depressive disorder patients correlated with disease severity. J Affect Disord. 2016 Nov 1;204:159-65. doi: 10.1016/j.jad.2016.06.039. Epub 2016 Jun 17.
- Yildiz M, Alim S, Batmaz S, Demir S, Songur E, Ortak H, Demirci K. Duration of the depressive episode is correlated with ganglion cell inner plexifrom layer and nasal retinal fiber layer thicknesses: Optical coherence tomography findings in major depression. Psychiatry Res Neuroimaging. 2016 May 30;251:60-6. doi: 10.1016/j.pscychresns.2016.04.011. Epub 2016 Apr 18.
- Maruani J, Geoffroy PA. Multi-Level Processes and Retina-Brain Pathways of Photic Regulation of Mood. J Clin Med. 2022 Jan 16;11(2):448. doi: 10.3390/jcm11020448.
- Benarroch EE. The melanopsin system: Phototransduction, projections, functions, and clinical implications. Neurology. 2011 Apr 19;76(16):1422-7. doi: 10.1212/WNL.0b013e31821671a5. No abstract available.
- Filippatou AG, Calabresi PA, Saidha S, Murphy OC. Spotlight on Trans-Synaptic Degeneration in the Visual Pathway in Multiple Sclerosis. Eye Brain. 2023 Dec 29;15:153-160. doi: 10.2147/EB.S389632. eCollection 2023.
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Studiet fullført (Antatt)
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Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ORT-2026-001
- 2024.06665.BD (Annet stipend/finansieringsnummer: Foundation for Science and Technology (FCT), Portugal)
- CE0085E (Annen identifikator: Ethics Committee of the School of Health of the Polytechnic Institute of Porto)
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