Dopamine and Brain Computer Interface

NCT06729658 | Completed Early Phase 1

• 1 other identifier: BCI_LDOPA_01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The use of Brain-Computer Interface system (BCI system) allows for the detection of neurophysiological signals on the surface of the head and provides feedback to subjects or patients. For patients with neurological disorders who have severe motor deficits, self-generated brain signals can be translated, for example, into orthosis-supported movement of the paralyzed limb. Another possibility is to translate the brain signal into peripheral electrostimulation (functional electrical stimulation, FES), which generates muscle contraction and thus movement. Fundamentally, BCI technology can be used as a replacement therapy when no recovery of motor function is expected. Another important application lies in improving motor training, relearning, and initiating movements. In the latter case, it is hoped that BCI training will stimulate neuroplastic mechanisms that lead to functional improvement. Problems on the translational path to clinical application are:

• The high interindividual variability between different people regarding learning to control the BCI system;
• The extent of learning and motor improvement is often limited For this reason, the present study aims to investigate whether dopaminergic influence on the brain affects the effectiveness of using a BCI system in healthy subjects.

Conditions

Healthy Participants

Keywords

Dopamine; Brain Computer Interface; Motor control; Neuroplasticity; MRI; Quantitative MRI; Diffusion MRI

Outcome Measures

Primary Outcomes (11)

• Changes in brain structure as assessed by MTsat

  Characterization of underlying structural changes by comprehensive assessment of brain tissue properties, allowing for sensitive detection of subtle neuroplastic changes across magnetization transfer saturation (MTsat) before and after the intervention.

  Total of 4 MRIs: 1 MRI 1 week before the intervention, 1 MRI the day before the intervention week, 1 MRI 1 day after the intervention week, and 1 MRI 1 week after.

• Changes in brain structure as assessed by PD

  Characterization of underlying structural changes by comprehensive assessment of brain tissue properties, allowing for sensitive detection of subtle neuroplastic changes across proton density (PD) before and after the intervention.

  Total of 4 MRIs: 1 MRI 1 week before the intervention, 1 MRI the day before the intervention week, 1 MRI 1 day after the intervention week, and 1 MRI 1 week after.

• Changes in brain structure as assessed by R1

  Characterization of underlying structural changes by comprehensive assessment of brain tissue properties, allowing for sensitive detection of subtle neuroplastic changes across longitudinal transverse relaxation rate R1 before and after the intervention.

  Total of 4 MRIs: 1 MRI 1 week before the intervention, 1 MRI the day before the intervention week, 1 MRI 1 day after the intervention week, and 1 MRI 1 week after.

• Changes in brain structure as assessed by R2*

  Characterization of underlying structural changes by comprehensive assessment of brain tissue properties, allowing for sensitive detection of subtle neuroplastic changes across effective transverse relaxation rate R2\* before and after the intervention.

  Total of 4 MRIs: 1 MRI 1 week before the intervention, 1 MRI the day before the intervention week, 1 MRI 1 day after the intervention week, and 1 MRI 1 week after.

• White matter changes as assessed by DWI (FA)

  Characterization of underlying structural changes across fractional anisotropy (FA) before and after the intervention.

  Total of 4 MRIs: 1 MRI 1 week before the intervention, 1 MRI the day before the intervention week, 1 MRI 1 day after the intervention week, and 1 MRI 1 week after.

• White matter changes as assessed by DWI (MD)

  Characterization of underlying structural changes across mean diffusivity (MD) before and after the intervention.

  Total of 4 MRIs: 1 MRI 1 week before the intervention, 1 MRI the day before the intervention week, 1 MRI 1 day after the intervention week, and 1 MRI 1 week after.

• White matter changes as assessed by DWI (AD)

  Characterization of underlying structural changes across axial diffusivity (AD) before and after the intervention.

  Total of 4 MRIs: 1 MRI 1 week before the intervention, 1 MRI the day before the intervention week, 1 MRI 1 day after the intervention week, and 1 MRI 1 week after.

• White matter changes as assessed by DWI (RD)

  Characterization of underlying structural changes across radial diffusivity (RD) before and after the intervention.

  Total of 4 MRIs: 1 MRI 1 week before the intervention, 1 MRI the day before the intervention week, 1 MRI 1 day after the intervention week, and 1 MRI 1 week after.

• White matter changes as assessed by DWI (g-ratio)

  Characterization of underlying structural changes assessed by ratio of the inner axonal diameter to the total outer diameter (g-ratio) before and after the intervention.

  Total of 4 MRIs: 1 MRI 1 week before the intervention, 1 MRI the day before the intervention week, 1 MRI 1 day after the intervention week, and 1 MRI 1 week after.

• Functional connectivity changes due to neuroplasticity (rs-fMRI)

  Characterization of underlying functional changes by comprehensive assessment of brain connectivity properties using resting-state fMRI before and after the intervention.

  Total of 4 MRIs: 1 MRI 1 week before the intervention, 1 MRI the day before the intervention week, 1 MRI 1 day after the intervention week, and 1 MRI 1 week after.

• Functional and structural brain changes due to neuroplasticity (t-fMRI)

  Characterization of underlying functional changes by comprehensive assessment of brain activity and connectivity properties using task-based fMRI before and after the intervention.

  Total of 4 MRIs: 1 MRI 1 week before the intervention, 1 MRI the day before the intervention week, 1 MRI 1 day after the intervention week, and 1 MRI 1 week after.

Secondary Outcomes (2)

• BCI classification accuracy

  1 week

• Time needed to achieve above chance-level BCI accuracy.

  1 week

Study Arms (2)

Interventional group - Levodopa

EXPERIMENTAL

Arm Description: Participants will receive Levodopa followed by BCI-mediated training for 6 days.

Drug: Madopar

Control group - Placebo

PLACEBO COMPARATOR

Arm Description: Participants will receive Placebo followed by BCI-mediated training for 6 days.

Drug: Placebo

Interventions

Madopar DRUG

Experimental group participants will receive Madopar 125mg for 6 days.

Also known as: Levodopa

Interventional group - Levodopa

Placebo DRUG

Control group participants will receive placebo for 6 days.

Also known as: A pill without any active components.

Control group - Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: between 18 and 80 years old at the time of signing the consent form
• BCI naïve
• MRI compatible
• Participation in a detailed discussion on the explanation of the experiment
• Signing of consent to participate in each experiment

You may not qualify if:

• Sensory deficits (visual and auditory)
• Wernicke's or global aphasia
• Strong spasticity
• Neurological and/or psychiatric diseases
• Severe pre-existing lung or heart diseases; Gastrointestinal diseases; Malignant disease
• Thyroid diseases
• Taking other medications
• Narrow angle glaucoma
• Non-age-related otological diseases
• Stimulators (cardiac, neuro, etc.)
• Participation in a similar study
• Fractures or lesions in the upper extremities
• Preceding neurosurgical procedures
• Inability to perform the experimental tasks
• Inability to give consent

Sponsors & Collaborators

• Max Planck Institute for Human Cognitive and Brain Sciences: lead

Study Sites (1)

Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences

Leipzig, 04103, Germany

Location

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MeSH Terms

Interventions

benserazide, levodopa drug combination; Levodopa

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Arno Villringer, PhD

  Max Planck Institute for Human Cognitive and Brain Sciences

  STUDY DIRECTOR

• Bernhard Sehm, PhD

  Max Planck Institute for Human Cognitive and Brain Sciences

  PRINCIPAL INVESTIGATOR

• Khosrov A. Grigoryan, MSc

  Max Planck Institute for Human Cognitive and Brain Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded randomized placebo-controlled intervention with 2 arms: BCI intervention with Placebo; BCI intervention with Levodopa

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: December 11, 2024
• Study Start: October 1, 2017
• Primary Completion: February 27, 2023
• Study Completion: August 6, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)