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

Primary Purpose

Frontal Lobe Dysfunction

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
sulforaphane
placedo
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frontal Lobe Dysfunction focused on measuring Sulforaphane, frontal brain damage, cognitive deficits, cognitive function, brain metabolites, gut microbiota

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    sulforaphane

    placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    T1-weighted spin-echo MRI
    It can be used as outcome measures in therapeutic trials

    Full Information

    First Posted
    January 27, 2020
    Last Updated
    May 17, 2020
    Sponsor
    Xiangya Hospital of Central South University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04252261
    Brief Title
    Effects of Sulforaphane on Cognitive Function in Patients With Frontal Brain Damage
    Official Title
    Effects of Sulforaphane on Cognitive Function in Patients With Frontal Brain Damage: Study Protocol for a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Xiangya Hospital of Central South University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frontal Lobe Dysfunction
    Keywords
    Sulforaphane, frontal brain damage, cognitive deficits, cognitive function, brain metabolites, gut microbiota

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Participants and researchers are blind to the treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    sulforaphane
    Arm Type
    Experimental
    Arm Description
    To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage
    Intervention Type
    Drug
    Intervention Name(s)
    sulforaphane
    Intervention Description
    To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage
    Intervention Type
    Drug
    Intervention Name(s)
    placedo
    Intervention Description
    To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage
    Primary Outcome Measure Information:
    Title
    Changes from baseline cognitive tests scores at 3 months
    Description
    The battery of cognitive tests include different domains of cognitive tests, higher scores indicates better cognition.
    Time Frame
    Week 1 and week 12.
    Secondary Outcome Measure Information:
    Title
    the resting state MRI (rsMRI)
    Description
    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.
    Title
    T1-weighted spin-echo MRI
    Description
    It can be used as outcome measures in therapeutic trials
    Time Frame
    Week 0, 4, and 12.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhixiong Liu
    Phone
    +8615874290600
    Email
    zhixiongliu@csu.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The study protocol and informed consent form are available on request to the corresponding author.
    IPD Sharing Time Frame
    2021-2022
    IPD Sharing Access Criteria
    The sharing data for this study are available on request to the corresponding author
    Citations:
    PubMed Identifier
    33067279
    Citation
    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.
    Results Reference
    derived

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

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