RecruitingNot Applicable

Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression

Israel142 participantsStarted 2023-11-08

Plain-language summary

The study evaluates the effect of HBOT on depression in patients suffering from persistent symptoms of post stroke depression (PSD) in an double blind sham control study.

Who can participate

Age range50 Years – 85 Years

SexALL

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Inclusion criteria

✓. Age between 50 -85
✓. Suffered an ischemic stroke 6 months to 7 years prior to their inclusion
✓. Treated or being treated by antidepressants for at least 3 months
✓. Diagnosis of PSD based on HDRS-17 score of 17 and above.
✓. Stable psychological and pharmacological treatment for more than three months prior to inclusion.
✓. Subject willing and able to read, understand and sign an informed consent.

Exclusion criteria

✕. Inability to attend scheduled clinic visits and/or comply with the study protocol
✕. Diagnosis of a psychiatric disorder prior to the recent stroke including: major depression, schizophrenia or bipolar disease.
✕. Diagnosis of aphasia or major cognitive decline
✕. History of Deep brain stimulation (DBS)
✕. History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy
✕. Active malignancy
✕. Substance use at baseline.
✕. History of other neurodegenerative diseases including Alzheimer's disease (AD), Parkinson's disease (PD), Lewy body dementia (LBD), Frontotemporal dementia (FTD), Multiple sclerosis (MS), Amyotrophic lateral sclerosis (ALS), Creutzfeld Jacob disease (CJD), Multisystem atrophy (MSA), Pseudobulbar palsy (PSP), Corticobasal degeneration (CBD), Wernicke Korsakoff syndrome

What they're measuring

PSD symptoms

Timeframe: Change from Baseline immediately after the intervention

Trial details

NCT IDNCT07423273

SponsorAssaf-Harofeh Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2030-12-01

Contact for this trial

Shai a Efrati, MD

972549212866 efratishai@outlook.com

View on ClinicalTrials.gov More Post Stroke Depression trials