Parkinson DiseaseDyn-fMRI-PDNCT06240624
Mapping Levodopa Effects on Cortico-basal Ganglia Circuit Function in Parkinson's Disease
An observational study of Parkinson Disease, run by Danish Research Centre for Magnetic Resonance at 1 site in Denmark.
Trial summary
Levodopa-induced dyskinesia (LID) in Parkinson's disease (PD) are involuntary movements caused by long-term treatment with dopaminergic replacement therapy (levodopa). During the cause of PD, most patients develop LID. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers, age- and sex-matched the PD groups
Who may be able to join
- Aged 18 or more
Who cannot join
- Pregnancy or breastfeeding
- History of other neurologic or psychiatric disease
- History of epilepsy or familiar dispositions of epilepsy
- Pacemaker or other implanted metallic or electronic devices which contraindicate MRI or TMS of the brain
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Research Centre for Magnetic Resonance, Hvidovre Hospital
Hvidovre, Danmark, 2650
About this study
Official title: Dynamic Brain Mapping of the Functional Effects of Levodopa on Multiple Cortex-basal Ganglia Circuits in Parkinson ́s Disease
Levodopa-induced dyskinesia (LID) in Parkinson's disease (PD) are involuntary movements caused by long-term treatment with dopaminergic replacement therapy (levodopa). During the cause of PD, most patients develop LID. In this study, the investigators plan to investigate how the cortico-basal-ganglia networks are affected in LID. The investigators will examine PD patients with and without LID as well as healthy age-matched controls using fMRI and PET. During the fMRI experiment, participants will perform a novel go-no task engaging both motor, emotional and reward brain networks. Patients will be scanned before and after intake of levodopa to study the dynamic effects of dopaminergic therapy. Furthermore, a dopamine transporter PET will be acquired to study the dopaminergic degeneration of the patients with PD.
Read the detailed description
BACKGROUND Parkinson's disease (PD) is a neurodegenerative disease affecting the cortico-basal-ganglia network including dopaminergic degeneration. PD is treated with dopaminergic replacement therapy such as levodopa which is a natural precursor of dopamine. Unfortunately, most patients develop involuntary movements after many years of treatment which are called levodopa-induced dyskinesia (LID). Little is known about how brain networks are disturbed in LID. To investigate this, the investigators will conduct a multimodal characterization of PD patients with LID. Patients with and without LID will be studied using dynamic task-based fMRI to trace the levodopa-induced changes in functional brain activity and connectivity in the transition from the off-to-on medication state. For the task-based fMRI, the investigators will employ a novel experimental task that concurrently engages motor, emotional, and reward networks. Furthermore, the investigators will also map and quantify the dopaminergic presynaptic deficit using dopamine transporter (DAT) PET ([18F]PE2I-PET) to correlate the findings with MRI.
This study is part of a larger study of brain phenotyping PD (ADAPT-PD) with MRI.
AIM This sub-study aims to achieve a multimodal characterization of LID in PD using both fMRI and DAT PET. Furthermore, both motor, reward and emotional cortico-basal-ganglia networks will be investigated. The result of this study will lay the foundation of a future non-invasive brain stimulation study using transcranial magnetic stimulation (TMS) in PD.
HYPOTHESES
- Patients with LID will show increased responsiveness to an acute levodopa challenge which will lead to a stronger time-dependent increase in striato-cortical motor network activity (preSMA and putamen) during NoGo trials after levodopa intake compared to patients without LID (Herz et al., 2014).
- Patients with LID will show increased activity in the SMA and pre-SMA and less activity of the rIFG during movement (go responses) compared to patients without LID in the off-medication state (Cerasa et al., 2012).
- Patients with LID will show abnormal levodopa-induced, task-related connectivity between putamen and and M1 compared to patients without LID (Herz et al., 2015).
- Patients with LID will show decreased dopamine transporter activity in putamen compared to patients without LID (Hong et al. 2014).
The analysis regarding reward and emotional processing in patients with LID and the comparisons between fMRI and PET will be exploratory as no previous studies have been conducted.
RESEARCH PLAN For the sub-study, the investigators aim to recruit 25 PD patients with LID, 25 PD patients without LID, and 25 age-matched healthy controls.
- Conditions
- Parkinson Disease
- Being tested
- No intervention
- Keywords
- Levodopa-induced dyskinesia, Parkinson's disease, fMRI
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be given.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson's disease and Levodopa-induced dyskinesia | Inclusion criteria:
* Aged 18 or more
* Clinically established or probable PD according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease
* Peak-of-dose levodopa-induced dyskinesia
* Stable antiparkinsonian medicine for 4 weeks
* Signed informed consent
Exclusion criteria:
* Pregnancy or breastfeeding
* History of other neurologic or psychiatric disease
* Pacemaker or other implanted metallic or electronic devices which contraindicate MRI or TMS of the brain
* Claustrophobia Receives: Other: No intervention | |
| Patients with Parkinson's disease without Levodopa-induced dyskinesia | Inclusion criteria:
* Aged 18 or more
* Clinically established or probable PD according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease
* No levodopa-induced dyskinesia
* Stable antiparkinsonian medicine for 4 weeks
* Signed informed consent
Exclusion criteria:
* Pregnancy or breastfeeding
* History of other neurologic or psychiatric disease
* Pacemaker or other implanted metallic or electronic devices which contraindicate MRI or TMS of the brain
* Claustrophobia Receives: Other: No intervention | |
| Healthy controls | Inclusion criteria:
* Aged 18 or more
* Age- and sex-matched the PD groups
* Signed informed consent
Exclusion criteria:
* Pregnancy or breastfeeding
* History of other neurologic or psychiatric disease
* Pacemaker or other implanted metallic or electronic devices which contraindicate MRI or TMS of the brain
* Claustrophobia Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores During Modified Go/No-Go Task
For each participant and each run, we will create general linear models with 20 regressors of interest.
The regressors are Motor: Right, Left, and No-Go trials Emotion: Happy, Neutral, Sad Reward: High/low reward, high/low loss All above regressors will be separately modeled for the high- and the low-reward context.
We will add a linear time modulation to all regressors to model dynamic changes in activation over time.
Measured: 4 task runs of 10 minutes each
Peak force
Measured with grip-force response. The data will be smoothed and normalized to the individual maximum voluntary contraction.
Measured: 4 task runs of 10 minutes each
Reaction time
Measured with grip-force response.
Measured: 4 task runs of 10 minutes each
Maximum slope
Maximum value of first derivative of grip-force curve. Measured with grip-force response. The data will be smoothed and normalized to the individual maximum voluntary contraction.
Measured: 4 task runs of 10 minutes each
Maximal negative slope
Maximum negative value of first derivative of grip-force curve. Measured with grip-force response. The data will be smoothed and normalized to the individual maximum voluntary contraction.
Measured: 4 task runs of 10 minutes each
Parkinson's disease severity
Total Unified Parkinson's Disease Rating Scale (UPDRS) score (sum of all 4 subscores listed below, range 0-199, higher values = worse outcome), UPDRS-1 (Cognitive and mental disease severity, range 0-16, higher values = worse outcome), UPDRS-2 (disease severity in relation to activities of daily living, range 0-52, higher values = worse outcome) and UPDRS-3 (Motor severity, range 0-108, higher values = worse outcome), UPDRS-4 (Complications of therapy, range 0-23, higher values = worse outcome) subscores. Measured while subjects are taking their usual medication.
Measured: Baseline (normal medication)
Motor disease severity
Unified Parkinson's Disease Rating Scale (UPDRS)-3 subscore (Motor severity, range 0-108, higher values = worse outcome). Measured while subjects are taking their usual medication.
Unified Parkinson's Disease Rating Scale (UPDRS)-3 subscore (Motor severity, range 0-108, higher values = worse outcome). Measured while subjects are taking their usual medication.
Unified Parkinson's Disease Rating Scale (UPDRS)-3 subscore (Motor severity, range 0-108, higher values = worse outcome). Measured while subjects are taking their usual medication.
Measured: Before and 30-60 minutes after 150 % of normal morning levodopa dose as Madopar Quick.
Non-motor disease severity
Total Non-Motor Symptom Scale (NMSS) score (range 0-360, higher values = worse outcome). Measured while subjects are taking their usual medication.
Measured: Baseline
Non-motor fluctuation severity
Total Non-Motor Fluctuation Assessment (NoMoFA) score (range 0-84, higher values = more severe non-motor fluctuations). Measured while subjects are taking their usual medication.
Measured: Baseline
Modified Hoehn and Yahr Staging
Modified Hoehn and Yahr Staging (Crude measure of disease severity, range 0-5, higher score = worse outcome). Measured while subjects are taking their usual medication.
Measured: Baseline
Schwab and England Activities of Daily Living Scale
Schwab and England Activities of Daily Living Scale (Measure of ADL function, range 100-0%, higher score = better ADL function). Measured while subjects are taking their usual medication.
Measured: Baseline
Apathy
Total Lille Apathy Rating Scale (LARS) score (range -36-36, higher score = higher degree of apathy).
Measured: Baseline
Depression
Major Depression Inventory (MDI) score (range 0-50), higher score = higher degree of depression
Measured: Baseline
Impulsive-Compulsive Disorders (ICD)
Questionnaire for Impulsive-Compulsive Disorders (QUIP) (range 0-112), higher score = higher degree of ICD
Measured: Baseline
Cognitive function
The Montreal Cognitive Assessment (MoCA) (range 0-30), higher score = better cognitive performance
Measured: Baseline
Impulsivity
Barratt Impulsiveness Scale (BIS-11) (range 30-120), higher score = higher level of impulsivity.
Measured: Baseline
Dyskinesia severity
Unified Dyskinesia Rating Scale (UDysRS)
Measured: Baseline (usual medication intake) as well as before and 30-60 minutes after 150 % of normal morning levodopa dose as Madopar Quick (range 0-104), higher score = higher dyskinesia severity
Dopaminergic degeneration
Dopamine transporter (presynaptic) binding in the basal ganglia is measured using Fluorine-18 N-(3-iodopro-2E-enyl)-2beta-carbomethoxy-3beta-(4'-methylphenyl) nortropane Positron Emission Tomography to
Measured: Baseline
Age
Measured: Baseline
Disease duration of Parkinson's disease
Measured: Baseline
Duration of levodopa-induced dyskinesia
Measured: Baseline
Medication
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Aug 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Research Centre for Magnetic Resonance
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240624
- Sponsor's protocol ID
- H-22010296
- Acronym
- Dyn-fMRI-PD
- Status last verified
- Mar 2025
- First submitted
- 28 Sep 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Brain Mapping of the Functional Effects of Levodopa on Multiple Cortex-basal Ganglia Circuits in Parkinson ́s Disease
- ClinicalTrials.gov ID
- NCT06240624
- Acronym / sponsor ID
- Dyn-fMRI-PD / H-22010296
- Conditions
- Parkinson Disease
- Keywords
- Levodopa-induced dyskinesia, Parkinson's disease, fMRI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Danish Research Centre for Magnetic ResonanceUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Feb 2024 (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.
Levodopa-induced dyskinesia (LID) in Parkinson's disease (PD) are involuntary movements caused by long-term treatment with dopaminergic replacement therapy (levodopa). During the cause of PD, most patients develop LID. In this study, the investigators plan to investigate how the cortico-basal-ganglia networks are affected in LID. The investigators will examine PD patients with and without LID as well as healthy age-matched controls using fMRI and PET. During the fMRI experiment, participants will perform a novel go-no task engaging both motor, emotional and reward brain networks. Patients will be scanned before and after intake of levodopa to study the dynamic effects of dopaminergic therapy. Furthermore, a dopamine transporter PET will be acquired to study the dopaminergic degeneration of the patients with PD.
Detailed description
BACKGROUND Parkinson's disease (PD) is a neurodegenerative disease affecting the cortico-basal-ganglia network including dopaminergic degeneration. PD is treated with dopaminergic replacement therapy such as levodopa which is a natural precursor of dopamine. Unfortunately, most patients develop involuntary movements after many years of treatment which are called levodopa-induced dyskinesia (LID). Little is known about how brain networks are disturbed in LID. To investigate this, the investigators will conduct a multimodal characterization of PD patients with LID. Patients with and without LID will be studied using dynamic task-based fMRI to trace the levodopa-induced changes in functional brain activity and connectivity in the transition from the off-to-on medication state. For the task-based fMRI, the investigators will employ a novel experimental task that concurrently engages motor, emotional, and reward networks. Furthermore, the investigators will also map and quantify the dopaminergic presynaptic deficit using dopamine transporter (DAT) PET ([18F]PE2I-PET) to correlate the findings with MRI.
This study is part of a larger study of brain phenotyping PD (ADAPT-PD) with MRI.
AIM This sub-study aims to achieve a multimodal characterization of LID in PD using both fMRI and DAT PET. Furthermore, both motor, reward and emotional cortico-basal-ganglia networks will be investigated. The result of this study will lay the foundation of a future non-invasive brain stimulation study using transcranial magnetic stimulation (TMS) in PD.
HYPOTHESES
- Patients with LID will show increased responsiveness to an acute levodopa challenge which will lead to a stronger time-dependent increase in striato-cortical motor network activity (preSMA and putamen) during NoGo trials after levodopa intake compared to patients without LID (Herz et al., 2014).
- Patients with LID will show increased activity in the SMA and pre-SMA and less activity of the rIFG during movement (go responses) compared to patients without LID in the off-medication state (Cerasa et al., 2012).
- Patients with LID will show abnormal levodopa-induced, task-related connectivity between putamen and and M1 compared to patients without LID (Herz et al., 2015).
- Patients with LID will show decreased dopamine transporter activity in putamen compared to patients without LID (Hong et al. 2014).
The analysis regarding reward and emotional processing in patients with LID and the comparisons between fMRI and PET will be exploratory as no previous studies have been conducted.
RESEARCH PLAN For the sub-study, the investigators aim to recruit 25 PD patients with LID, 25 PD patients without LID, and 25 age-matched healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's disease and Levodopa-induced dyskinesia | – | Other: No interventionInclusion criteria: * Aged 18 or more * Clinically established or probable PD according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease * Peak-of-dose levodopa-induced dyskinesia * Stable antiparkinsonian medicine for 4 weeks * Signed informed consent Exclusion criteria: * Pregnancy or breastfeeding * History of other neurologic or psychiatric disease * Pacemaker or other implanted metallic or electronic devices which contraindicate MRI or TMS of the brain * Claustrophobia |
| Patients with Parkinson's disease without Levodopa-induced dyskinesia | – | Other: No interventionInclusion criteria: * Aged 18 or more * Clinically established or probable PD according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease * No levodopa-induced dyskinesia * Stable antiparkinsonian medicine for 4 weeks * Signed informed consent Exclusion criteria: * Pregnancy or breastfeeding * History of other neurologic or psychiatric disease * Pacemaker or other implanted metallic or electronic devices which contraindicate MRI or TMS of the brain * Claustrophobia |
| Healthy controls | – | Other: No interventionInclusion criteria: * Aged 18 or more * Age- and sex-matched the PD groups * Signed informed consent Exclusion criteria: * Pregnancy or breastfeeding * History of other neurologic or psychiatric disease * Pacemaker or other implanted metallic or electronic devices which contraindicate MRI or TMS of the brain * Claustrophobia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers, age- and sex-matched the PD groups
Key inclusion criteria (1 listed)
- Aged 18 or more
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding
- History of other neurologic or psychiatric disease
- History of epilepsy or familiar dispositions of epilepsy
- Pacemaker or other implanted metallic or electronic devices which contraindicate MRI or TMS of the brain
- Claustrophobia
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 |
|---|---|---|
| No interventionNo intervention will be given. | Other | Healthy controls, Patients with Parkinson's disease and Levodopa-induced dyskinesia, Patients with Parkinson's disease without Levodopa-induced dyskinesia |
Primary outcome
Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores During Modified Go/No-Go Task
Time frame: 4 task runs of 10 minutes each
For each participant and each run, we will create general linear models with 20 regressors of interest. The regressors are Motor: Right, Left, and No-Go trials Emotion: Happy, Neutral, Sad Reward: High/low reward, high/low loss All above regressors will be separately modeled for the high- and the low-reward context. We will add a linear time modulation to all regressors to model dynamic changes in activation over time.
Peak force
Time frame: 4 task runs of 10 minutes each
Measured with grip-force response. The data will be smoothed and normalized to the individual maximum voluntary contraction.
Reaction time
Time frame: 4 task runs of 10 minutes each
Measured with grip-force response.
Maximum slope
Time frame: 4 task runs of 10 minutes each
Maximum value of first derivative of grip-force curve. Measured with grip-force response. The data will be smoothed and normalized to the individual maximum voluntary contraction.
Maximal negative slope
Time frame: 4 task runs of 10 minutes each
Maximum negative value of first derivative of grip-force curve. Measured with grip-force response. The data will be smoothed and normalized to the individual maximum voluntary contraction.
Parkinson's disease severity
Time frame: Baseline (normal medication)
Total Unified Parkinson's Disease Rating Scale (UPDRS) score (sum of all 4 subscores listed below, range 0-199, higher values = worse outcome), UPDRS-1 (Cognitive and mental disease severity, range 0-16, higher values = worse outcome), UPDRS-2 (disease severity in relation to activities of daily living, range 0-52, higher values = worse outcome) and UPDRS-3 (Motor severity, range 0-108, higher values = worse outcome), UPDRS-4 (Complications of therapy, range 0-23, higher values = worse outcome) subscores. Measured while subjects are taking their usual medication.
Motor disease severity
Time frame: Before and 30-60 minutes after 150 % of normal morning levodopa dose as Madopar Quick.
Unified Parkinson's Disease Rating Scale (UPDRS)-3 subscore (Motor severity, range 0-108, higher values = worse outcome). Measured while subjects are taking their usual medication. Unified Parkinson's Disease Rating Scale (UPDRS)-3 subscore (Motor severity, range 0-108, higher values = worse outcome). Measured while subjects are taking their usual medication. Unified Parkinson's Disease Rating Scale (UPDRS)-3 subscore (Motor severity, range 0-108, higher values = worse outcome). Measured while subjects are taking their usual medication.
Non-motor disease severity
Time frame: Baseline
Total Non-Motor Symptom Scale (NMSS) score (range 0-360, higher values = worse outcome). Measured while subjects are taking their usual medication.
Non-motor fluctuation severity
Time frame: Baseline
Total Non-Motor Fluctuation Assessment (NoMoFA) score (range 0-84, higher values = more severe non-motor fluctuations). Measured while subjects are taking their usual medication.
Modified Hoehn and Yahr Staging
Time frame: Baseline
Modified Hoehn and Yahr Staging (Crude measure of disease severity, range 0-5, higher score = worse outcome). Measured while subjects are taking their usual medication.
Schwab and England Activities of Daily Living Scale
Time frame: Baseline
Schwab and England Activities of Daily Living Scale (Measure of ADL function, range 100-0%, higher score = better ADL function). Measured while subjects are taking their usual medication.
Apathy
Time frame: Baseline
Total Lille Apathy Rating Scale (LARS) score (range -36-36, higher score = higher degree of apathy).
Depression
Time frame: Baseline
Major Depression Inventory (MDI) score (range 0-50), higher score = higher degree of depression
Impulsive-Compulsive Disorders (ICD)
Time frame: Baseline
Questionnaire for Impulsive-Compulsive Disorders (QUIP) (range 0-112), higher score = higher degree of ICD
Cognitive function
Time frame: Baseline
The Montreal Cognitive Assessment (MoCA) (range 0-30), higher score = better cognitive performance
Impulsivity
Time frame: Baseline
Barratt Impulsiveness Scale (BIS-11) (range 30-120), higher score = higher level of impulsivity.
Dyskinesia severity
Time frame: Baseline (usual medication intake) as well as before and 30-60 minutes after 150 % of normal morning levodopa dose as Madopar Quick (range 0-104), higher score = higher dyskinesia severity
Unified Dyskinesia Rating Scale (UDysRS)
Dopaminergic degeneration
Time frame: Baseline
Dopamine transporter (presynaptic) binding in the basal ganglia is measured using Fluorine-18 N-(3-iodopro-2E-enyl)-2beta-carbomethoxy-3beta-(4'-methylphenyl) nortropane Positron Emission Tomography to
Age
Time frame: Baseline
Disease duration of Parkinson's disease
Time frame: Baseline
Duration of levodopa-induced dyskinesia
Time frame: Baseline
Medication
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Danish Research Centre for Magnetic Resonance at 1 site in Denmark.
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 1 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores During Modified Go/No-Go Task (time frame: 4 task runs of 10 minutes each). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2025.