German Clinical Trials Register

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Brief summary in lay language

In this study we examine patients with the disease Progressive Supranuclear Paralysis, which belongs to the atypical parkinsonian syndromes. The aim is to further characterize the disorder and also to investigate the possible benefit from the antidepressant venlafaxine for cognitive as well as motor functions. The assumption is that venlafaxine, as a serotonin and norepinephrine reuptake inhibitor, can lead to an improvement not only in thinking performance but possibly also in movement control by increasing the norepinephrine concentration, which is usually low in PSP subjects. The study can be divided into three parts. In the first part, pupil size (pupillometry), measured with a kind of "spectacle frame" with implemented, small camera systems and the cortical brain activity, measured by an Electroencephalography (EEG) using a wireless "cap" with integrated electrodes, are recorded simultanously. Here, there are measurement blocks at rest while sitting relaxed and looking forward, and measurement blocks while listening to a sequence of tones. In the second part, the patient's gait is recorded using a pressure-sensitive carpet, at the same time brain activity is measured. Finally, in the last part, the patient is interviewed regarding disease-specific categories, neurologically examined and cognitively tested. These measurements are performed in patients before they start taking venlafaxine and then a second time 4 to 6 weeks later, in order to assess the effect of venlafaxine. To compare the patients with healthy people of the same age, cognitive tests, assessment of gait and pupil size as well as the EEG are also performed on control subjects - they do not receive venlafaxine.

Brief summary in scientific language

The aim of this interventional, monocentric study is to characterize patients with Progressive Supranuclear Paralysis clinically, kinematically and electrophysiologically, and to further evaluate the efficacy of venlafaxine on the patient's motor and non-motor symptoms. Hypotheses are that 1. the neurodegeneration and tau protein aggregation in the Locus coeruleus, exhibited by PSP patients, contributes significantly to the deficit of the noradrenergic system, 2. that this deficit is related to the heterogeneous clinical picture. Thus, in addition to further characterize the disease, the relationship between the pathophysiological transmitter deficit and the clinical symptoms as well as the potential benefit from the the serotonin-norepinephrine reuptake inhibitor venlafaxine will be investigated in the PSP group. The study consists of 3 parts, each conducted before and after a venlafaxine intake of at least 4 weeks. In the first part, pupil data (using Pupil Labs eye tracker) and EEG data are recorded simultaneously, twice during an auditory oddball experiment and three times at rest for 3.5 minutes each. In the second part, kinematic data are collected with the GaitRite system, simultaneously an EEG is recorded. Here, the patient walks over a pressure-sensitive mat in 3 conditions, at normal pace, at maximum speed and during a dual-task. In the third part, a disease-specific interview, a neurological examination (PSP-RS) and cognitive tests (MoCA, TMT, word fluency, three clap test, Luria sequence) are performed. In addition, there are questionnaires (GDS, SAS, PSP-QoL, MDT). To characterize the disease as well as evaluate the effect of venlafaxine, clinical scores, cognitive tests, questionnaires as well as kinematic and electrophysiological markers will be compared within the PSP group before and after venlafaxine intake for 4-6 weeks, and will further be compared to data from healthy control subjects NOT receiving venlafaxine.