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

NCT ID: NCT04252261

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

sulforaphane

To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage

Group Type: EXPERIMENTAL

sulforaphane

Intervention Type: DRUG

To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage

placebo

To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage

Group Type: PLACEBO_COMPARATOR

placedo

Intervention Type: DRUG

To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage

Interventions

sulforaphane

To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage

Intervention Type: DRUG

placedo

To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Zhixiong Liu

Role: CONTACT

zhixiongliu@csu.edu.cn

+8615874290600

References

Liu F, Huang J, Hei G, Wu R, Liu Z. Effects of sulforaphane on cognitive function in patients with frontal brain damage: study protocol for a randomised controlled trial. BMJ Open. 2020 Oct 16;10(10):e037543. doi: 10.1136/bmjopen-2020-037543.

Reference Type: DERIVED

PMID: 33067279 (View on PubMed)

Other Identifiers

202001005

Identifier Type: -

Identifier Source: org_study_id