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

May 17, 2020 updated by: Xiangya Hospital of Central South University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline cognitive tests scores at 3 months
Time Frame: Week 1 and week 12.
The battery of cognitive tests include different domains of cognitive tests, higher scores indicates better cognition.
Week 1 and week 12.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the resting state MRI (rsMRI)
Time Frame: 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.
Week 0 and 12.
T1-weighted spin-echo MRI
Time Frame: Week 0, 4, and 12.
It can be used as outcome measures in therapeutic trials
Week 0, 4, and 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

January 27, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (ACTUAL)

February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 17, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202001005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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