Effects of Sulforaphane on Cognitive Function in Patients With Frontal Brain Damage
Słowa kluczowe
Abstrakcyjny
Opis
90 patients aged 18-65 years, of both genders, who have incurred cognitive deficits after frontal brain damage will be recruited in the neurosurgery department in Xiangya hospital. All focal lesions were confined to the frontal brain, which is verified by CT or MRI. Cognitive deficits will be diagnosed using the Chinese version of the Montreal Cognitive Assessment (MoCA-C). All eligible recruited patients will be randomly divided into two groups in a 2:1 ratio. Participants will receive a battery of cognitive tests at baseline and again after 4 and 12 weeks to determine the effect of sulforaphane on cognition. T1-weighted brain magnetic resonance images and resting-state functional MRI will be carried out using 3 Tesla (3T) brain MRI at these timepoints. Brain magnetic resonance spectrum will be applied to detect MRI markers of brain metabolites and gut microbiota will also be assessed over this period.
Daktyle
| Ostatnia weryfikacja: | 04/30/2020 |
| Pierwsze przesłane: | 01/26/2020 |
| Szacowana liczba przesłanych rejestracji: | 01/30/2020 |
| Wysłany pierwszy: | 02/04/2020 |
| Ostatnia aktualizacja przesłana: | 05/16/2020 |
| Ostatnia opublikowana aktualizacja: | 05/18/2020 |
| Rzeczywista data rozpoczęcia badania: | 05/31/2020 |
| Szacowana data zakończenia podstawowej działalności: | 12/30/2021 |
| Szacowana data zakończenia badania: | 12/30/2021 |
Stan lub choroba
Interwencja / leczenie
Drug: sulforaphane
Drug: placebo
Faza
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| Experimental: sulforaphane To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage | Drug: sulforaphane To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage |
| Placebo Comparator: placebo To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage | Drug: placebo To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
| Płeć kwalifikująca się do nauki | All |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | Inclusion Criteria: - 18-65 years old - Focal lesions were confined to the frontal brain, which is verified by CT or MRI - Clinical diagnosis of Cognitive deficits using the Chinese version of the Montreal Cognitive Assessment (MoCA-C) with scores < 26 will be assessed as having cognitive deficits (<25 for patients educated <12 years) - be adherent to the continued sulforaphane treatment medication Exclusion Criteria: - Previous history of cognitive impairment - Brain MRI indicating damage was not restricted to the frontal lobe. - Inability to cooperate with cognitive testing for disturbance of consciousness or mental disorder - Pregnancy or maternal lactation - Life expectancy < 3 months - CO poisoning, autoimmune encephalitis, intracranial infection, or other types of diffuse intracranial disease. - plan to receive radiotherapy during the trial period - Laboratory examination showing liver and kidney insufficiency or other severe complications; the presence of diseases which may interfere with the results of the evaluation - Involvement in other trials 1 month prior to the start of the trial or during the trial period |
Wynik
Podstawowe miary wyników
1. Changes from baseline cognitive tests scores at 3 months [Week 1 and week 12.]
Miary wyników wtórnych
1. the resting state MRI (rsMRI) [Week 0 and 12.]
2. T1-weighted spin-echo MRI [Week 0, 4, and 12.]
