Clincosm LogoSign in Get a demo

Brain-REG: Brain Self-regulation for Parkinson's

Sponsor
Maastricht University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05627895
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
13
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate feasibility of basal-ganglia regions as fMRI-neurofeedback targets in Parkinson's patients and evaluate self-regulation success

Condition or Disease Intervention/Treatment Phase
  • Other: Neurofeedback
 N/A

Detailed Description

This is a single-group proof of mechanism study of Parkinson's Disease (PD) patients receiving neurofeedback (NF) training using supplementary motor area (SMA) and basal ganglia as target areas. At the start of the screening session, consent will be taken. Subsequently, the screening assessment will be performed to determine inclusion and exclusion criteria. After inclusion in the study has been established, the NF sessions at the MRI scanner will be scheduled. The participants will be invited for up to three NF sessions. This will total up to a maximum of four visits, one for screening and up to three for the NF sessions. Due to the feasibility nature of the study, the optimal number of sessions for the patient cohort to learn the NF regulation is unknown. Therefore, flexibility has been introduced in the design to facilitate learning in case it is necessary. The NF training is modelled on the investigators' previous work.

Each NF session will consist of one anatomical scan, one localizer run, and four functional NF runs. The localizer run will be used to identify individualized brain activation patterns in the participants. Each NF run is a measurement sequence that will consist of ten blocks: five regulation blocks and five rest blocks. The participants will be asked to upregulate (increase) their brain activity, which will be displayed on a thermometer bar, during the regulation blocks. During the rest blocks, the participants will be asked to relax. The study will employ a crossover design with two conditions. In one condition the participants will receive feedback on the thermometer bar from the SMA region and in the second condition the participants will receive feedback from the basal ganglia region. Two of the NF runs will be with the SMA condition and two will be with the basal ganglia condition. Both runs in each condition will take place consecutively, i.e., either the first two runs will be SMA and the second two runs will be basal ganglia or vice versa. The sessions will be counter balanced.

At the last NF session, a post-training assessment will be conducted during which the participants will be debriefed about the study. NF is an individualized training method, and therefore, individual differences in learning success are expected during the study, which can lead to different expectations from the subjects. However, since this is an investigation of the feasibility of the approach, all forms of performance are useful datapoints and participants will be debriefed about their valuable contribution to make sure that no outcome is conceived as negative.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The study will employ a crossover design with two conditions. In one condition the participants will receive feedback on the thermometer bar from the SMA region and in the second condition the participants will receive feedback from the basal ganglia region. Two of the NF runs will be with the SMA condition and two will be with the basal ganglia condition. Both runs in each condition will take place consecutively, i.e., either the first two runs will be SMA and the second two runs will be basal ganglia or vice versa. The sessions will be counter balanced in the design.The study will employ a crossover design with two conditions. In one condition the participants will receive feedback on the thermometer bar from the SMA region and in the second condition the participants will receive feedback from the basal ganglia region. Two of the NF runs will be with the SMA condition and two will be with the basal ganglia condition. Both runs in each condition will take place consecutively, i.e., either the first two runs will be SMA and the second two runs will be basal ganglia or vice versa. The sessions will be counter balanced in the design.
Masking:
None (Open Label)
Masking Description:
The participants won't be aware from which brain region we will be measuring the fMRI activations
Primary Purpose:
Other
Official Title:
A Feasibility Study of fMRI-neurofeedback in Parkinson's Disease
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patient cohort

All patients will undergo both the SMA and the basal ganglia condition

Other: Neurofeedback
Participants will be shown their brain activity measured in real-time using an MRI scanner. They can then use mental strategies, such as imagination to influence and regulate this activity.
Other Names:
  • fMRI based neurofeedback
  • Self-regulation of brain activity using neurofeedback

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of basal-ganglia neurofeedback training (fMRI analysis) [Measurements will be recorded at each MRI session (approx. 1 week intervals after screening and inclusion)]

      We will be investigating the ability of the basal ganglia to be used as a neurodeedback target for self-regulation in PD patients. To determine the ability of the basal ganglia to be recruited in the neurofeedback training, we will look at the T-contrast of all basal ganglia regulation blocks vs all baseline blocks in all the runs where basal ganglia was the target region.

    Secondary Outcome Measures

    1. Performance of basal-ganglia neurofeedback training (fMRI analysis) [Measurements will be recorded at each MRI session (approx. 1 week intervals after screening and inclusion)]

      To determine the performance of basal ganglia self-regulation, we will employ a T-contrast of all runs with the basal ganglia as the target region versus all the runs with the SMA as the target region. Additionally, we will assess whole-brain activation changes in the basal ganglia runs to determine specificity of the neurofeedback training. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of Parkinson's disease (see 4.1) according to Movement Disorder Society (MDS) clinical diagnostic criteria (Postuma et al., 2015).

    • Disease stage 1-3 according to the Hoehn and Yahr Scale

    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

    • Advanced cognitive impairment (MoCA <24) or dementia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maastricht University Maastricht Netherlands 6229ER

    Sponsors and Collaborators

    • Maastricht University

    Investigators

    • Principal Investigator: David EJ Linden, Prof., Maastricht University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Maastricht University
    ClinicalTrials.gov Identifier:
    NCT05627895
    Other Study ID Numbers:
    • NL82024.068.22
    First Posted:
    Nov 28, 2022
    Last Update Posted:
    Dec 1, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maastricht University
    Neurofeedback
    Self-regulation
    Functional MRI
    Additional relevant MeSH terms:
    Ganglion Cysts

    Study Results

    No Results Posted as of Dec 1, 2022