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

Xiangya Hospital of Central South University90 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changes from baseline cognitive tests scores at 3 months

The battery of cognitive tests include different domains of cognitive tests, higher scores indicates better cognition.

Time frame: Week 1 and week 12.

Secondary Outcomes

the resting state MRI (rsMRI)

It can be served as a powerful tool to map networks of "functional connectivity" in the brain even in the absence of task activation or stimulation.

Time frame: Week 0 and 12.

T1-weighted spin-echo MRI

It can be used as outcome measures in therapeutic trials

Time frame: Week 0, 4, and 12.