Effects of altitude-like cognition training on brain function and cognitive abilities
Altitude-like Cognition Training to Target Brain Erythropoietin as a Novel Mechanism of Long-lasting Neuroplasticity and Cognitive Functions
This study tests if a special brain training program that mimics high-altitude conditions can improve thinking skills and brain function in both healthy people and those with mood disorders.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Mental Health Services in the Capital Region, Denmark Academic / other |
| Locations | 1 site (Copenhagen, Capital Region Of Copenhagen) |
| Trial ID | NCT06121206 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a three-week altitude-like cognition training intervention on cognitive functions and neuroplasticity in both healthy individuals and patients with mood disorders. Participants will engage in cognitive training while exposed to low oxygen levels, simulating high-altitude conditions, to assess improvements in cognition and brain activity. The study includes two substudies: one focusing on healthy individuals and the other on symptomatically stable patients with bipolar disorder or depression. Outcomes will be measured through cognitive assessments and brain imaging before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals aged 18-50 and patients aged 18-65 with a diagnosis of bipolar disorder or depression who are in partial or full remission.
Not a fit: Patients with severe psychiatric histories or those not fluent in Danish may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to significant improvements in cognitive function for individuals with mood disorders and enhance neuroplasticity.
How similar studies have performed: While the approach is innovative, similar studies exploring cognitive training and hypoxia have shown promising results, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (substudy 1): * 18-50 years * No psychiatric history * Fluency in Danish Inclusion Criteria (substudy 2): * 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)
Where this trial is running
Copenhagen, Capital Region Of Copenhagen
- Neurocognition and Emotion in Affective Disorders (NEAD) Centre, University of Copenhagen and Psychiatric Centre Copenhagen, Frederiksberg hospital — Copenhagen, Capital Region Of Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Kamilla W Miskowiak, DMSc, DPhil — Mental Health Services in the Capital Region, Denmark
- Study coordinator: Kamilla W Miskowiak, DMSc, DPhil
- Email: kamilla.woznica.miskowiak@regionh.dk
- Phone: +4522771617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.