Potentiation of procedural motor learning by pharmacological neuromodulation and brain stimulation - Potentiation of procedural motor learning

Phase 1

• Conditions: Healthy volunteersPatients in the chronic stage (> 1 year) after stroke

• Registration Number: EUCTR2004-004129-89-DE
• Lead Sponsor: niversitätsklinikum Münster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-08
• Study Completion: 2007-11-30
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Healthy subjects: Only individuals with a normal neurological examination, free of antipsychotic, antidepressant drugs, and drugs affecting the dopaminergic system, and a Mini-Mental-State Examination of > 27 will be included.
Chronic stroke patients: They will be eligible if they had a cortical or subcortical stroke with an initial severe hemiparesis MRC scale < 2 that has recovered to a degree that they are able to perform the proposed task (in general > MRC 4.5, with low spasticity, work in progress on motor learning in stroke patients). They will have to be free of antipsychotic and antidepressant drugs, and drugs affecting the dopaminergic system, and a score > 27 on a Mini-Mental-State Examination. Only premorbid right-handed subjects, as assessed by the Edinburgh handedness inventory will be included.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Severe and untreated renal and liver insufficiency
- Severe and untreated cardiovascular disease, pulmonary disease, endocrine, metabolic, hematopetic disease,
- untreated glaucoma
- peptic ulcer
- melanoma or other skin cancer
- intracranial metallic or magnetic implants (other than the mouth) (Part II and Part III)
- cardiac pacemaker (Part II and Part III)
- Psychiatric disease, neurological disease other than stroke in stroke patient population
- antipsychotic or antidepressive medication
- known adverse reaction against levodopa or carbidopa
- Drug or alcohol (more than 50 mg per day) abuse ·
- Epilepsy, intracranial tumor
- more than 6 cups of coffee per day
- more than 15 cigarettes per day
- pregnancy (in women of childbearing age; a safe method for contraception and a urine pregnancy test are mandatory)

specifically for stroke patients:
- more than one cerebral infarction, or bilateral infarction
- brain stem infarction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified