NCT06121206Befejeződött
Effects of Altitude-like Cognition Training on Neuroplasticity and Cognitive Functions
Altitude-like Cognition Training to Target Brain Erythropoietin as a Novel Mechanism of Long-lasting Neuroplasticity and Cognitive Functions
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. szept. 26.
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to investigate the effects of a three-week altitude-like cognition training intervention in healthy individuals (substudy 1) and symptomatically stable patients with mood disorders (depression or bipolar disorder; substudy 2). This multi-modal intervention consists of an adaptive cognitive training programme that participants complete while they're inside an altitude-training room with 12% O2, corresponding to 4400 meters altitude. Across substudy 1 and 2, the investigators hypothesize that altitude-like cognition training has a beneficial effect on cognition after three-weeks treatment completion measured with a global cognition composite score (primary outcome measure). Further, the investigators hypothesize that hypoxia and cognition training will yield improved executive functioning after treatment completion and changes in brain activity during working memory in the dorsal prefrontal cortex 4 weeks after treatment completion (secondary outcome measures). In the patient study, the investigators further hypothesize that the intervention will have beneficial effects on daily-life cognition measured in virtual reality (VR) 4 weeks after treatment completion (secondary outcome measure in substudy 2). For exploratory purposes, the study will examine effects on additional measures of cognition, functioning and self-ratings scales (tertiary outcomes). The investigators will compare the combination of altitude-like hypoxia (12%) and cognitive training with (1) hypoxia with no training, (2) cognitive training under normal oxygen levels (normoxia; 20%), and (3) normoxia with no training in healthy individuals (substudy 1). For patients with mood disorders (substudy 2) the effects of altitude-like hypoxia (12%) and cognitive training are compared to treatment as usual (TAU).
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 190 (tényleges)
- Első benyújtás
- 2023. okt. 31.
- Kezdés
- 2023. febr. 1.
- Elsődleges befejezés
- 2025. júl. 1.
- Fő szponzor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Betegségek
- Bipoláris zavar
- NCT-szám
- NCT06121206
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 190
- 2023. febr. 1. és az elsődleges befejezés (2025. júl. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Kiket keres a vizsgálat
- 18-50 years
- No psychiatric history
- Fluency in Danish
- 18-65 years
- International Classification of Diseases (ICD)-10 diagnosis of Bipolar Disorder or depression confirmed with the Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
- Fluency in Danish
- Partial or full remission (defined as a score of ≤14 on the Hamilton Depression Rating Scale 17-items (HDRS-17) and the Young Mania Rating Scale (YMRS)
- Objectively-verified cognitive impairment according to Screen for Cognitive Impairment in Psychiatry (SCIP) and/or self-reported cognitive impairment measured with Cognitive Complaints in Bipolar disorder Rating Assessment (COBRA). For SCIP, their performance must be ≥0.5 standard deviations (SD) below their demographically adjusted expected total SCIP score or on minimum 2 SCIP subtest scores. For COBRA, patients must report substantial cognitive impairment defined as a score ≥14.
- Common Exclusion Criteria:
- Schizophrenia or schizoaffective disorder
- Neurological disorder
- Alcohol or substance abuse
- History of serious head trauma
- Previous altitude sickness
- Heart disease
- Diabetes
- Renal failure
- Untreated/insufficiently treated hypertension
- Thromboses or thromboembolic events
- First-degree family with thromboembolic events before age 60
- Pregnancy
- Breastfeeding
- Smoking or use other nicotine products regularly
- BMI>30
- Electroconvulsive therapy (ECT) 3 months prior to participation
- Dyslexia
- Claustrophobia (MRI scans)
- Pacemaker and/or other MRI incompatible metal implants (MRI scans)
- Participation in experiments with radioactivity (>10 mSv) within the last year (PET scans)
- Significant occupational exposure to radioactivity (PET scans)
- Medication incompatible with study aims (e.g., SV2A binding agents; PET scans)
Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Neurocognition and Emotion in Affective Disorders (NEAD) Centre, University of Copenhagen and Psychiatric Centre Copenhagen, Frederiksberg hospital | Copenhagen | Dánia | Ismeretlen állapot |
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