Parkinson DiseaseMOTOR-NFNCT06582355
FMRI-neurofeedback in Parkinson's Disease
A study testing Neurofeedback and Kinesthetic imagery in people with Parkinson Disease, run by Maastricht University Medical Center at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Neurofeedback and Kinesthetic imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Feb 2025to Dec 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease.
- Disease stage 1-3 according to the Hoehn and Yahr Scale
- Age: 18 years or more
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Not yet recruiting
Uniklinik Köln
Cologne
Martin Kocher
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht
David Linden, +31433881021, pd-neurofeedback-np@maastrichtuniversity.nl
About this study
Official title: MOTOR-NF - a Randomized Controlled Trial of FMRI-based Neurofeedback for Motor Symptoms of Parkinson's Disease
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.
Read more
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.
Read the detailed description
Parkinson's disease (PD) is associated with progressive neurodegeneration of dopaminergic neurons of the substantia nigra. It is characterized by both motor and non-motor system manifestations. Dopamine replacement therapy or dopaminergic medication are the key therapeutic strategies, but deep brain stimulation (DBS) is increasingly being used in cases where drug response is/ has become insufficient or hampered by unacceptable side effects.
Neurofeedback (NF) entails training of self-regulation of brain regions or networks via mental imagery and real-time feedback of neural signals, for example obtained by functional MRI (fMRI). NF enables patients to develop personal strategies that are most effective in self-regulating brain areas and networks. Thereby, it can provide an individually tailored intervention. NF is a highly sustainable form of non-invasive neuromodulation because, once learnt, the self-regulation strategies can in principle be applied by patients whenever needed to overcome disease symptomology.
NF can be used to train patients to change their brain activity in different directions, or to modulate patterns of co-activation between regions. Mental imagery of moving one's own body (also called kinaesthetic imagery) can potentially be used to improve motor functions and neuroplasticity in PD. Kinaesthetic imagery is also a suitable strategy for increasing activation in the brain's motor network, and motor imagery training can be reinforced through combination with NF. A NF paradigm involving upregulation training of motor areas through kinaesthetic imagery thus has good plausibility for PD. The PI's group has shown proof-of-concept of such an fMRI-NF training (targeting the supplementary motor area, SMA) in PD and has recently completed a feasibility study of fMRI-NF targeting the putamen in 12 PD patients (NCT05627895). The aim of the current investigator-initiated study is to investigate the effects of putamen upregulation training on motor function and other outcome parameters in PD.
- Conditions
- Parkinson Disease
- Being tested
- Neurofeedback, Kinesthetic imagery
- Keywords
- Parkinson Disease, Neurofeedback, 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.
NeurofeedbackOther
The participants will be instructed to use cognitive strategies to upregulate (increase) their brain activity in the selected brain region, with the suggestion that motor imagery may be particularly effective, for example, mental imagery of swimming or playing a musical instrument. During the rest blocks, the participants will be instructed to relax. The instructions to start and stop the regulation and rest blocks are visualized on a screen in the scanner, and the brain activity of the putamen will be displayed in real-time using a thermometer bar for visualization.
Kinesthetic imageryOther
The participants will be instructed to imagine movements during the active blocks. During the rest blocks, the participants will be instructed to relax. The instructions to start and stop the regulation and rest blocks are visualized on a screen in the scanner. No feedback is provided regarding brain activity.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | Four weekly MRI sessions where they will learn to upregulate the activity of the putamen during motor imagery via fMRI neurofeedback. Receives: Other: Neurofeedback |
| Kinesthetic imagery | Active comparator | Four weekly MRI sessions with motor imagery without fMRI neurofeedback. Receives: Other: Kinesthetic imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDS-UPDRS (Unified Parkinson's Disease Rating Scale)
Pre versus Post-interventional change in the MDS-UPDRS (Unified Parkinson's Disease Rating Scale) motor scale will be compared using t statistics.
The MDS-UPDRS contains 65 scores, each with a range from 0 (no impairment) to 4 (severe impairment).
The total scale ranges between 0 - 260, with 0 indicating no impairment and 260 indicating the highest level of impairment.
As primary outcome measure we will use Part III: Motor Examination, which has 33 scores. The measurement at the last MRI session will be the primary endpoint.
Measured: After screening, after the last MRI session (approx. 5 weeks after screening) and at follow up session (approx. 4 weeks after final MRI session)
Secondary outcomes (4)
Performance of Putamen neurofeedback training (fMRI analysis)
To determine the performance of Putamen self-regulation, we will employ an region of interest (ROI) general linear model analysis, using a T-contrast of all blocks with the Putamen as the target region versus all the baseline blocks. This will allow us to assess recruitment of the Putamen during the training as well as regulation success.
Furthermore we will use an ANOVA F-contrast to check for any interactions of the neurofeedback training with sessions (eg., if Session 4 shows improved neurofeedback success as compared to Session 1).
Measured: Measurements will be recorded at each MRI session (approx. 1 week intervals after screening and inclusion)
Whole brain activation pattern changes (fMRI analysis)
We will investigate the whole brain level activation pattern changes due to neurofeedback training using self-regulation in PD patients. To determine these changes, we will look at the T-contrast of all regulation blocks vs all baseline blocks in all the fMRI runs with neurofeedback. This can give us insight into which brain networks contribute mechanistically to the training and if any of the training performance can be attributed to other factors, such as physiological measures, as compared to neurofeedback self-regulation.
Measured: Measurements will be recorded at each MRI session (approx. 1 week intervals after screening and inclusion)
Neurofeedback training effects on non-motor symptoms
Effect of neurofeedback training on non-motor symptoms will be assessed using the MDS-UPDRS part I, II, IV and the Hospital Anxiety and Depression Scale (HADS).
The MDS-UPDRS contains 65 scores, each with a range from 0 (no impairment) to 4 (severe impairment).
The Part I subscore, indicating nonmotor experiences of daily living has a total of 13 items with scores ranging between 0-52.
The HADS is a widely used questionnaire designed to assess levels of anxiety and depression in patients. It consists of 14 items, with seven questions related to anxiety (HADS-A) and seven related to depression (HADS-D). Each item is scored on a scale from 0 to 3, with total scores ranging from 0 to 21 for each subscale. The HADS is commonly used in clinical settings to identify and measure the severity of anxiety and depression in patients, particularly in hospital environments.
Measured: After screening, after the last MRI session (approx. 5 weeks after screening) and at follow up session (approx. 4 weeks after final MRI session)
Correlation between NF success and distal finger tapping test (behavioral measure)
We will correlate neurofeedback success with the distal finger tapping (DFT) test scores to determine if NF success can lead to improvements in behavioral measures.
Three kinetic parameters are generated by the DFT test: kinesia score (KS20), the number of keystrokes in a 20 second time period, reflecting speed; akinesia time (AT20), average dwell time that keys are depressed, reflecting akinesia; and incoordination score (IS20), the variance of travelling time between keystrokes, reflecting rhythm. A higher KS20 score represents improvement, a lower AT20 score represents improvement and a smaller variance in the IS20 score represents improvement.
Measured: After screening, after the last MRI session (approx. 5 weeks after screening) and at follow up session (approx. 4 weeks after final MRI session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start10 Feb 2025
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David EJ Linden, Prof., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582355
- Sponsor's protocol ID
- NL86308.068.24
- Acronym
- MOTOR-NF
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akram N, Li H, Ben-Joseph A, Budu C, Gallagher DA, Bestwick JP, Schrag A, Noyce AJ, Simonet C. Developing and assessing a new web-based tapping test for measuring distal movement in Parkinson's disease: a Distal Finger Tapping test. Sci Rep. 2022 Jan 10;12(1):386. doi: 10.1038/s41598-021-03563-7.
PubMed 35013372Emmert K, Kopel R, Sulzer J, Bruhl AB, Berman BD, Linden DEJ, Horovitz SG, Breimhorst M, Caria A, Frank S, Johnston S, Long Z, Paret C, Robineau F, Veit R, Bartsch A, Beckmann CF, Van De Ville D, Haller S. Meta-analysis of real-time fMRI neurofeedback studies using individual participant data: How is brain regulation mediated? Neuroimage. 2016 Jan 1;124(Pt A):806-812. doi: 10.1016/j.neuroimage.2015.09.042. Epub 2015 Sep 28.
PubMed 26419389Esmail, S., & Linden, D. E. J. (2014). Neural Networks and Neurofeedback in Parkinson's Disease. NeuroRegulation, 1(3-4), 240-240. https://doi.org/10.15540/nr.1.3-4.240
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Hamilton JP, Glover GH, Bagarinao E, Chang C, Mackey S, Sacchet MD, Gotlib IH. Effects of salience-network-node neurofeedback training on affective biases in major depressive disorder. Psychiatry Res Neuroimaging. 2016 Mar 30;249:91-6. doi: 10.1016/j.pscychresns.2016.01.016. Epub 2016 Jan 19.
PubMed 26862057Jaeckle T, Williams SCR, Barker GJ, Basilio R, Carr E, Goldsmith K, Colasanti A, Giampietro V, Cleare A, Young AH, Moll J, Zahn R. Self-blame in major depression: a randomised pilot trial comparing fMRI neurofeedback with self-guided psychological strategies. Psychol Med. 2023 May;53(7):2831-2841. doi: 10.1017/S0033291721004797. Epub 2021 Dec 2.
PubMed 34852855Johnston SJ, Boehm SG, Healy D, Goebel R, Linden DE. Neurofeedback: A promising tool for the self-regulation of emotion networks. Neuroimage. 2010 Jan 1;49(1):1066-72. doi: 10.1016/j.neuroimage.2009.07.056. Epub 2009 Jul 29.
PubMed 19646532Karch, S., Keeser, D., Paolini, M., Hümmer, S., Konrad, J., Haller, D., Kirsch, V., Koller, G., Kupka, M., Blautzik, J., & Pogarell, O. (2015). Real-time fMRI neurofeedback: Applica-tion in patients with substance use disorder. Pharmacopsychiatry, 25(6), A77. https://doi.org/10.1055/s-0035-1558015
Linden DE. Neurofeedback and networks of depression. Dialogues Clin Neurosci. 2014 Mar;16(1):103-12. doi: 10.31887/DCNS.2014.16.1/dlinden.
PubMed 24733975Linden DE, Habes I, Johnston SJ, Linden S, Tatineni R, Subramanian L, Sorger B, Healy D, Goebel R. Real-time self-regulation of emotion networks in patients with depression. PLoS One. 2012;7(6):e38115. doi: 10.1371/journal.pone.0038115. Epub 2012 Jun 4.
PubMed 22675513MacDuffie KE, MacInnes J, Dickerson KC, Eddington KM, Strauman TJ, Adcock RA. Single session real-time fMRI neurofeedback has a lasting impact on cognitive behavioral therapy strategies. Neuroimage Clin. 2018 Jun 9;19:868-875. doi: 10.1016/j.nicl.2018.06.009. eCollection 2018.
PubMed 29922575Mehler DMA, Sokunbi MO, Habes I, Barawi K, Subramanian L, Range M, Evans J, Hood K, Luhrs M, Keedwell P, Goebel R, Linden DEJ. Targeting the affective brain-a randomized controlled trial of real-time fMRI neurofeedback in patients with depression. Neuropsychopharmacology. 2018 Dec;43(13):2578-2585. doi: 10.1038/s41386-018-0126-5. Epub 2018 Jun 23.
PubMed 29967368Mehler DMA, Williams AN, Krause F, Luhrs M, Wise RG, Turner DL, Linden DEJ, Whittaker JR. The BOLD response in primary motor cortex and supplementary motor area during kinesthetic motor imagery based graded fMRI neurofeedback. Neuroimage. 2019 Jan 1;184:36-44. doi: 10.1016/j.neuroimage.2018.09.007. Epub 2018 Sep 8.
PubMed 30205210Paret C, Zaehringer J, Ruf M, Ende G, Schmahl C. The orbitofrontal cortex processes neurofeedback failure signals. Behav Brain Res. 2019 Sep 2;369:111938. doi: 10.1016/j.bbr.2019.111938. Epub 2019 May 6.
PubMed 31071348Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
PubMed 26474316
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOTOR-NF - a Randomized Controlled Trial of FMRI-based Neurofeedback for Motor Symptoms of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06582355
- Acronym / sponsor ID
- MOTOR-NF / NL86308.068.24
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Neurofeedback, fMRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Sep 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.
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.
Detailed description
Parkinson's disease (PD) is associated with progressive neurodegeneration of dopaminergic neurons of the substantia nigra. It is characterized by both motor and non-motor system manifestations. Dopamine replacement therapy or dopaminergic medication are the key therapeutic strategies, but deep brain stimulation (DBS) is increasingly being used in cases where drug response is/ has become insufficient or hampered by unacceptable side effects.
Neurofeedback (NF) entails training of self-regulation of brain regions or networks via mental imagery and real-time feedback of neural signals, for example obtained by functional MRI (fMRI). NF enables patients to develop personal strategies that are most effective in self-regulating brain areas and networks. Thereby, it can provide an individually tailored intervention. NF is a highly sustainable form of non-invasive neuromodulation because, once learnt, the self-regulation strategies can in principle be applied by patients whenever needed to overcome disease symptomology.
NF can be used to train patients to change their brain activity in different directions, or to modulate patterns of co-activation between regions. Mental imagery of moving one's own body (also called kinaesthetic imagery) can potentially be used to improve motor functions and neuroplasticity in PD. Kinaesthetic imagery is also a suitable strategy for increasing activation in the brain's motor network, and motor imagery training can be reinforced through combination with NF. A NF paradigm involving upregulation training of motor areas through kinaesthetic imagery thus has good plausibility for PD. The PI's group has shown proof-of-concept of such an fMRI-NF training (targeting the supplementary motor area, SMA) in PD and has recently completed a feasibility study of fMRI-NF targeting the putamen in 12 PD patients (NCT05627895). The aim of the current investigator-initiated study is to investigate the effects of putamen upregulation training on motor function and other outcome parameters in PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Other: NeurofeedbackFour weekly MRI sessions where they will learn to upregulate the activity of the putamen during motor imagery via fMRI neurofeedback. |
| Kinesthetic imagery | Active comparator | Other: Kinesthetic imageryFour weekly MRI sessions with motor imagery without fMRI neurofeedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Parkinson's disease.
- Disease stage 1-3 according to the Hoehn and Yahr Scale
- Age: 18 years or more
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| NeurofeedbackThe participants will be instructed to use cognitive strategies to upregulate (increase) their brain activity in the selected brain region, with the suggestion that motor imagery may be particularly effective, for example, mental imagery of swimming or playing a musical instrument. During the rest blocks, the participants will be instructed to relax. The instructions to start and stop the regulation and rest blocks are visualized on a screen in the scanner, and the brain activity of the putamen will be displayed in real-time using a thermometer bar for visualization. | Other | Neurofeedback |
| Kinesthetic imageryThe participants will be instructed to imagine movements during the active blocks. During the rest blocks, the participants will be instructed to relax. The instructions to start and stop the regulation and rest blocks are visualized on a screen in the scanner. No feedback is provided regarding brain activity. | Other | Kinesthetic imagery |
Primary outcome
MDS-UPDRS (Unified Parkinson's Disease Rating Scale)
Time frame: After screening, after the last MRI session (approx. 5 weeks after screening) and at follow up session (approx. 4 weeks after final MRI session)
Pre versus Post-interventional change in the MDS-UPDRS (Unified Parkinson's Disease Rating Scale) motor scale will be compared using t statistics. The MDS-UPDRS contains 65 scores, each with a range from 0 (no impairment) to 4 (severe impairment). The total scale ranges between 0 - 260, with 0 indicating no impairment and 260 indicating the highest level of impairment. As primary outcome measure we will use Part III: Motor Examination, which has 33 scores. The measurement at the last MRI session will be the primary endpoint.
4 secondary outcomes
Performance of Putamen neurofeedback training (fMRI analysis)
Time frame: Measurements will be recorded at each MRI session (approx. 1 week intervals after screening and inclusion)
Whole brain activation pattern changes (fMRI analysis)
Time frame: Measurements will be recorded at each MRI session (approx. 1 week intervals after screening and inclusion)
Neurofeedback training effects on non-motor symptoms
Time frame: After screening, after the last MRI session (approx. 5 weeks after screening) and at follow up session (approx. 4 weeks after final MRI session)
Correlation between NF success and distal finger tapping test (behavioral measure)
Time frame: After screening, after the last MRI session (approx. 5 weeks after screening) and at follow up session (approx. 4 weeks after final MRI session)
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 24 Mar 2025.
- Background: PubMed 35013372Akram N, Li H, Ben-Joseph A, Budu C, Gallagher DA, Bestwick JP, Schrag A, Noyce AJ, Simonet C. Developing and assessing a new web-based tapping test for measuring distal movement in Parkinson's disease: a Distal Finger Tapping test. Sci Rep. 2022 Jan 10;12(1):386. doi: 10.1038/s41598-021-03563-7.
- Background: PubMed 26419389Emmert K, Kopel R, Sulzer J, Bruhl AB, Berman BD, Linden DEJ, Horovitz SG, Breimhorst M, Caria A, Frank S, Johnston S, Long Z, Paret C, Robineau F, Veit R, Bartsch A, Beckmann CF, Van De Ville D, Haller S. Meta-analysis of real-time fMRI neurofeedback studies using individual participant data: How is brain regulation mediated? Neuroimage. 2016 Jan 1;124(Pt A):806-812. doi: 10.1016/j.neuroimage.2015.09.042. Epub 2015 Sep 28.
- BackgroundEsmail, S., & Linden, D. E. J. (2014). Neural Networks and Neurofeedback in Parkinson's Disease. NeuroRegulation, 1(3-4), 240-240. https://doi.org/10.15540/nr.1.3-4.240
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background: PubMed 26862057Hamilton JP, Glover GH, Bagarinao E, Chang C, Mackey S, Sacchet MD, Gotlib IH. Effects of salience-network-node neurofeedback training on affective biases in major depressive disorder. Psychiatry Res Neuroimaging. 2016 Mar 30;249:91-6. doi: 10.1016/j.pscychresns.2016.01.016. Epub 2016 Jan 19.
- Background: PubMed 34852855Jaeckle T, Williams SCR, Barker GJ, Basilio R, Carr E, Goldsmith K, Colasanti A, Giampietro V, Cleare A, Young AH, Moll J, Zahn R. Self-blame in major depression: a randomised pilot trial comparing fMRI neurofeedback with self-guided psychological strategies. Psychol Med. 2023 May;53(7):2831-2841. doi: 10.1017/S0033291721004797. Epub 2021 Dec 2.
- Background: PubMed 19646532Johnston SJ, Boehm SG, Healy D, Goebel R, Linden DE. Neurofeedback: A promising tool for the self-regulation of emotion networks. Neuroimage. 2010 Jan 1;49(1):1066-72. doi: 10.1016/j.neuroimage.2009.07.056. Epub 2009 Jul 29.
- BackgroundKarch, S., Keeser, D., Paolini, M., Hümmer, S., Konrad, J., Haller, D., Kirsch, V., Koller, G., Kupka, M., Blautzik, J., & Pogarell, O. (2015). Real-time fMRI neurofeedback: Applica-tion in patients with substance use disorder. Pharmacopsychiatry, 25(6), A77. https://doi.org/10.1055/s-0035-1558015
- Background: PubMed 24733975Linden DE. Neurofeedback and networks of depression. Dialogues Clin Neurosci. 2014 Mar;16(1):103-12. doi: 10.31887/DCNS.2014.16.1/dlinden.
- Background: PubMed 22675513Linden DE, Habes I, Johnston SJ, Linden S, Tatineni R, Subramanian L, Sorger B, Healy D, Goebel R. Real-time self-regulation of emotion networks in patients with depression. PLoS One. 2012;7(6):e38115. doi: 10.1371/journal.pone.0038115. Epub 2012 Jun 4.
- Background: PubMed 29922575MacDuffie KE, MacInnes J, Dickerson KC, Eddington KM, Strauman TJ, Adcock RA. Single session real-time fMRI neurofeedback has a lasting impact on cognitive behavioral therapy strategies. Neuroimage Clin. 2018 Jun 9;19:868-875. doi: 10.1016/j.nicl.2018.06.009. eCollection 2018.
- Background: PubMed 29967368Mehler DMA, Sokunbi MO, Habes I, Barawi K, Subramanian L, Range M, Evans J, Hood K, Luhrs M, Keedwell P, Goebel R, Linden DEJ. Targeting the affective brain-a randomized controlled trial of real-time fMRI neurofeedback in patients with depression. Neuropsychopharmacology. 2018 Dec;43(13):2578-2585. doi: 10.1038/s41386-018-0126-5. Epub 2018 Jun 23.
- Individual participant dataSharing planned: No
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Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
David EJ Linden, Prof. principal investigator
Maastricht University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback and Kinesthetic imagery in people with Parkinson Disease, run by Maastricht University Medical Center at 2 sites in 2 countries.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. 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?
Contact David EJ Linden, Prof. (+31 43 3881021, david.linden@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDS-UPDRS (Unified Parkinson's Disease Rating Scale) (time frame: After screening, after the last MRI session (approx. 5 weeks after screening) and at follow up session (approx. 4 weeks after final MRI session)). 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 NCT06582355, which also lists 23 linked publications.
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 24 Mar 2025.