Clinical trial NCT04252261: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Frontal Lobe Dysfunction
Keywords: Sulforaphane
frontal brain damage
cognitive deficits
cognitive function
brain metabolites
gut microbiota
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes from baseline cognitive tests scores at 3 months
timeFrame: Week 1 and week 12.
Secondary outcomes:
measure: the resting state MRI (rsMRI)
timeFrame: Week 0 and 12.
measure: T1-weighted spin-echo MRI
timeFrame: Week 0, 4, and 12.
Other outcomes:
Locations:
Study officials:
References:
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.