NCT06582355 FMRI-neurofeedback in Parkinson's Disease
| NCT ID | NCT06582355 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-02-10 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rationale: Current treatment of patients with Parkinson's disease (PD) is mainly based on the modulation of neural activity in the motor circuits of the basal ganglia and cerebral cortex by either drug intervention (dopamine replacement therapy or dopaminergic medication) or deep brain stimulation (DBS). However, many Parkinson patients have an insufficient (long-term) response to medical treatments, and DBS is an invasive procedure with resource implications and potential side effects. Moreover, not all patients are eligible for DBS. Therefore, new ways of administering neuromodulation are needed. A potential avenue may be self-regulation of brain circuits through neurofeedback. Self-regulation of motor circuits through mental imagery and neurofeedback using real-time functional MRI (fMRI) signals has already been shown to be feasible, and there are also preliminary data on clinical benefits of such self-regulation training. We here aim to use the non-invasive fMRI-neurofeedback method to train patients in the regulation of brain circuits that are implicated in successful drug treatment and/or DBS. Objective: To investigate brain mechanisms and efficacy of an fMRI-neurofeedback protocol that targets the brain's motor circuits through the basal ganglia. Study design: Randomised controlled trial Study population: Patients with Parkinson's disease Investigation: In the experimental group, fMRI-neurofeedback will be administered in 4 separate sessions of about 2 hours each over approximately one month. The MRI measurement in each session will be approximately 60 minutes long and include upregulation training of brain activity in specific target areas by mental imagery. The fMRI signals are processed such that the patients get visual feedback about the success of the upregulation. In addition, patients are asked to practice the self-regulation strategies on a daily basis at home between the neurofeedback sessions. The control intervention will consist of mental imagery without neurofeedback. Main study parameters/endpoints: Post-interventional improvement of motor symptoms of PD as assessed by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor scale in the on-medication state. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This is a low-risk study where the main burden is participation time and MRI scans.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of Parkinson's disease. * Disease stage 1-3 according to the Hoehn and Yahr Scale * Age: 18 years or more Exclusion Criteria: * Exclusion criteria for MRI (e.g., cardiac pacemaker, certain metallic implants) * History of psychotic disorder, bipolar disorder, or psychotic depression * Current use of illegal drugs (any in the last four weeks) * Current excessive alcohol consumption that interferes with daily functioning * A score on the Montreal Cognitive Assessment (MoCA) below 24/30. * Any disorder that would interfere with accurate and usable data acquisition.
Contact & Investigator
David EJ Linden, Prof.
PRINCIPAL INVESTIGATOR
Maastricht University
Frequently Asked Questions
Who can join the NCT06582355 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06582355 currently recruiting?
Yes, NCT06582355 is actively recruiting participants. Contact the research team at david.linden@maastrichtuniversity.nl for enrollment information.
Where is the NCT06582355 trial being conducted?
This trial is being conducted at Cologne, Germany, Maastricht, Netherlands.
Who is sponsoring the NCT06582355 clinical trial?
NCT06582355 is sponsored by Maastricht University Medical Center. The principal investigator is David EJ Linden, Prof. at Maastricht University. The trial plans to enroll 60 participants.
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