Frontal Lobe DysfunctionPhase 2NCT04252261
Effects of Sulforaphane on Cognitive Function in Patients With Frontal Brain Damage
A Phase 2 study testing sulforaphane and placedo in people with Frontal Lobe Dysfunction, run by Xiangya Hospital of Central South University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Frontal Lobe Dysfunction
- What is being tested?
- sulforaphane and placedo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Frontal Lobe Dysfunction
- Being tested
- sulforaphane, placedo
- Keywords
- Sulforaphane, frontal brain damage, cognitive deficits, cognitive function, brain metabolites, gut microbiota
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulforaphaneDrug
To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage
placedoDrug
To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage
| Study group | Role | What they receive |
|---|---|---|
| sulforaphane | Experimental | To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage Receives: Drug: sulforaphane |
| placebo | Placebo comparator | To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage Receives: Drug: placedo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1 and week 12.
Secondary outcomes (2)
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.
Measured: Week 0 and 12.
T1-weighted spin-echo MRI
It can be used as outcome measures in therapeutic trials
Measured: Week 0, 4, and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jun 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frontal Lobe DysfunctionStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252261
- Sponsor's protocol ID
- 202001005
- Status last verified
- May 2020
- First submitted
- 27 Jan 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and informed consent form are available on request to the corresponding author.
Publications
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.
PubMed 33067279
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sulforaphane on Cognitive Function in Patients With Frontal Brain Damage: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04252261
- Acronym / sponsor ID
- 202001005
- Conditions
- Frontal Lobe Dysfunction
- Keywords
- Sulforaphane, frontal brain damage, cognitive deficits, cognitive function, brain metabolites, gut microbiota
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sulforaphane | Experimental | Drug: sulforaphaneTo evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage |
| placebo | Placebo comparator | Drug: placedoTo evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sulforaphaneTo evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage | Drug | sulforaphane |
| placedoTo evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage | Drug | placebo |
Primary outcome
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.
2 secondary outcomes
the resting state MRI (rsMRI)
Time frame: Week 0 and 12.
T1-weighted spin-echo MRI
Time frame: Week 0, 4, and 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Derived from this study: PubMed 33067279Liu 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.
- Individual participant dataSharing planned: Yes. The study protocol and informed consent form are available on request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sulforaphane and placedo in people with Frontal Lobe Dysfunction, run by Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhixiong Liu (+8615874290600, zhixiongliu@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline cognitive tests scores at 3 months (time frame: Week 1 and week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.