The Effect of Dopaminergic Modulation on Brain Computer Interface Efficacy

Max Planck Institute for Human Cognitive and Brain Sciences1 个研究点分布在 1 个国家目标入组 22 人开始时间: 2017年10月1日最近更新: 2025年5月31日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 22
试验地点: 1
主要终点: Changes in brain structure as assessed by MTsat

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

Aims of the present research project are to assess the effect of dopaminergic modulation on BCI performance in healthy elderly subjects to understand the underlying neurophysiological mechanisms. The perspective lies in the application of this approach for improved motor recovery after stroke.

Stroke is one of the most common causes of motor function impairment, and its prevalence is expected to rise due to an aging population. Stroke survivors often experience some level of spontaneous recovery of motor function during the acute stage and reach a functional plateau after which the recovery is generally slow or stagnant. Interestingly, there is emerging evidence indicating that brain-computer interface (BCI) based therapies can induce recovery beyond this plateau.

Pharmacological MRI (phMRI) is a new and promising method to study the effects of substances on brain function that can ultimately be used to unravel underlying neurobiological mechanisms behind drug action. Like most of the imaging methods it represents a progress in the investigation of brain disorders and the related function of neurotransmitter pathways in a non-invasive way with respect of the overall neuronal connectivity.

Moreover, it provides an ideal tool for translation to clinical investigations. MRI, while still behind in molecular imaging strategies compared to PET and SPECT, has the advantage to have a high spatial resolution and no need for the injection of a contrast-agent or radio-labeled molecules, thereby avoiding the repetitive exposure to ionising radiations. Functional MRI (fMRI) is extensively used in research and clinical setting, where it is generally combined with a psycho-motor task. phMRI is an adaptation of fMRI enabling the investigation of a specific neurotransmitter system, such as dopamine, under physiological or pathological conditions following activation via administration of a specific challenging drug.

The importance of the neurotransmitter dopamine (DA) for motor processes has long been known. In patients suffering from the Parkinson's disease the dopamine deficiency in the basal ganglia is known to cause strong movement-related deficits.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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
•Have contraindication for magnetic resonance tomography (MRI) (e.g. braces, cardiac pacemakers, metallic implants that might interfere with the MR signal, claustrophobia)
•Severe attention and drive disorders
•Alcohol or drug abuse
•Pregnancy
•Women in breastfeeding period

研究组 & 干预措施

Interventional group - Levodopa

Experimental

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

干预措施: Madopar (Drug)

Control group - Placebo

Placebo Comparator

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

干预措施: Placebo (Drug)