Brain Self-regulation for Parkinson's (Brain-REG)

April 12, 2024 updated by: Maastricht University

A Feasibility Study of fMRI-neurofeedback in Parkinson's Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229ER
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's disease as per inclusion/ exclusion criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of basal-ganglia neurofeedback training (fMRI analysis)
Time Frame: 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.
Measurements will be recorded at each MRI session (approx. 1 week intervals after screening and inclusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of basal-ganglia neurofeedback training (fMRI analysis)
Time Frame: 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.
Measurements will be recorded at each MRI session (approx. 1 week intervals after screening and inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2023

Primary Completion (Actual)

February 19, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

November 16, 2022

First Posted (Actual)

November 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL82024.068.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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