ipRGC som en potentiell biomarkör för att förutsäga behandlingsrespons på transkraniell magnetstimulering vid större depressiv störning (BRIGHT)
Belysande depression: ipRGC som en potentiell biomarkör för att förutsäga behandlingssvar på transkraniell magnetstimulering vid större depressiv störning
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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Inês Duarte D Pais, MSc
- Telefonnummer: +351 222 061 000
- E-post: idp@ess.ipp.pt
Studera Kontakt Backup
- Namn: Catarina C Mateus, PhD
- Telefonnummer: +351 222 061 000
- E-post: cms@ess.ipp.pt
Studieorter
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Porto District
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Porto, Porto District, Portugal, 4200-072
- Rekrytering
- RISE-Health, Center for Translational Health and Medical Biotechnology Research (TBIO), School of Health, Polytechnic of Porto
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Kontakt:
- Nuno B Rocha, PhD
- Telefonnummer: +351 913474780
- E-post: nrocha@ess.ipp.pt
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Chromatic pupillometry
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Optical Coherence Tomography (OCT)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Catarina C Mateus, PhD, Polytechnic Institute of Porto
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ORT-2026-001
- 2024.06665.BD (Annat bidrag/finansieringsnummer: Foundation for Science and Technology (FCT), Portugal)
- CE0085E (Annan identifierare: Ethics Committee of the School of Health of the Polytechnic Institute of Porto)
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