Frontal Lobe Dysfunction Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 90 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Xiangya Hospital of Central South University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | |
| Secondary | 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. | |
| Secondary | T1-weighted spin-echo MRI | It can be used as outcome measures in therapeutic trials | Week 0, 4, and 12. |