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

Sponsor

Xiangya Hospital of Central South University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04252261

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frontal Lobe Dysfunction	Drug: sulforaphane Drug: placedo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Participants and researchers are blind to the treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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: placedo To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage

Arm

Intervention/Treatment

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: placedo

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

Outcome Measures

Primary Outcome Measures

Changes from baseline cognitive tests scores at 3 months [Week 1 and week 12.]
The battery of cognitive tests include different domains of cognitive tests, higher scores indicates better cognition.

Secondary Outcome Measures

the resting state MRI (rsMRI) [Week 0 and 12.]
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.
T1-weighted spin-echo MRI [Week 0, 4, and 12.]
It can be used as outcome measures in therapeutic trials

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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