CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 22 enrolled
Drug / intervention
Madopar +1 moredrug
Likely dose
Madopar 125mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06729658
NCT06729658Early Ph 1Completed

The Effect of Dopaminergic Modulation on Brain Computer Interface Efficacy

Max Planck Institute for Human Cognitive and Brain Sciences·interventional·Posted Dec 11, 2024·Updated May 31, 2025

In Brief

A Early Phase 1 clinical trial evaluating Madopar and Placebo for Healthy Participants. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

Early Ph 1CompletedFinished
201820192020202120222023202420252026
First PostedDec 11, 2024
Enrollment StartOct 1, 2017
Primary CompletionFeb 27, 2023
Study CompletionAug 6, 2024
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 1.6 years ago

Interventions

Madopardrug

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

Placebodrug

Control group participants will receive placebo for 6 days.