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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sulforaphane | Experimental | To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage |
|
| placebo | Placebo Comparator | To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sulforaphane | Drug | To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 1 and week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0 and 12. |
| T1-weighted spin-echo MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhixiong Liu | Contact | +8615874290600 | zhixiongliu@csu.edu.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33067279 | Derived | 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. |
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The study protocol and informed consent form are available on request to the corresponding author.
2021-2022
The sharing data for this study are available on request to the corresponding author
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| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C016766 | sulforaphane |
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Participants and researchers are blind to the treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.
| placedo | Drug | To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage |
|
It can be used as outcome measures in therapeutic trials
| Week 0, 4, and 12. |