NCT04252261

Effects of Sulforaphane on Cognitive Function in Patients With Frontal Brain Damage

Effects of Sulforaphane on Cognitive Function in Patients With Frontal Brain Damage: Study Protocol for a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

High rates of patients with frontal brain damage show serious cognitive functional deficits, which negatively impact their quality of life and are linked with poor clinical outcomes. Sulforaphane has shown significant antioxidant and cellular protective effects in animal models associated with oxidative stress, such as focal cerebral ischemia, brain inflammation, and intracranial hemorrhage. Preclinical research has shown that sulforaphane can significantly improve spatial localization and working memory impairment after brain damage. The primary aim of this clinical trial is to assess the efficacy of sulforaphane for improving cognitive function in patients with frontal brain damage.

Detailed description

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.

Conditions

• Frontal Lobe Dysfunction

Interventions

Type	Name	Description
DRUG	sulforaphane	To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage
DRUG	placedo	To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2020-02-05
• Last updated: 2020-05-19

Regulatory

• FDA-regulated drug study