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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004129-89-DE

Enrollment

200

Registered

2005-08-08

Start date

2005-09-19

Completion date

Unknown

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers Patients in the chronic stage (> 1 year) after stroke

Interventions

Trade Name: NACOM 100 Product Name: NACOM 100 Pharmaceutical Form: Capsule* INN or Proposed INN: Levodopa and Carbidopa Concentration unit: mg milligram(s) Concentration type: equal Concentration nu

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The overall purpose of the present proposal is to explore the possibilities offered by pharmacological neuromodulation and brain stimulation in both healthy individuals and in patients with brain damage. Main objective for Part I (Normal volunteers, Patients) of this trial: To enhance procedural motor learning in young and elderly healthy subjects and stroke patients with levodopa premedication . The primary outcome measure is "procedural motor learning (in ms) under levodopa", compared to "procedural motor learning (in ms under placebo".;Secondary Objective: For Part II to III of the trial, the main objekctives and outcome measures are: - Part II: objective: to enhance procedural motor learning for at least 24 hours in young and elderly healthy subjects and stroke patients with both trancranial direct current stimulation and levodopa outcome measure: procedural motor learning after 24 hours (in ms) under levodopa + transcranial direct current stimulation", compared to "procedural motor learning (in ms under placebo+ transcranial direct current stimulation". - Part III: objective: to examine the underlying neural mechanisms of levodopa-enhanced learning with functional magnetic resonance imaging. outcome measure: "increase in learning-related blood flow in the motor cortex after levodopa", compared to "increase in learning -related blood flow in the motor cortex after placebo";Primary end point(s): For the primary outcome measure, procedural motor learning performance (reaction times in ms) after levodopa-premedication, data will be submitted to an analysis of variance (ANOVA) with the factors CONDITION (placebo, levodopa) the factor GROUP (young healthy volunteer (HV), elderly HV, young stroke patient (SP), elderly SP) and the dependent variable test performance, followed by adequate post-hoc tests in the case of significance	—

Measure

Time frame

Main Objective: The overall purpose of the present proposal is to explore the possibilities offered by pharmacological neuromodulation and brain stimulation in both healthy individuals and in patients with brain damage. Main objective for Part I (Normal volunteers, Patients) of this trial: To enhance procedural motor learning in young and elderly healthy subjects and stroke patients with levodopa premedication . The primary outcome measure is "procedural motor learning (in ms) under levodopa", compared to "procedural motor learning (in ms under placebo".;Secondary Objective: For Part II to III of the trial, the main objekctives and outcome measures are: - Part II: objective: to enhance procedural motor learning for at least 24 hours in young and elderly healthy subjects and stroke patients with both trancranial direct current stimulation and levodopa outcome measure: procedural motor learning after 24 hours (in ms) under levodopa + transcranial direct current stimulation", compared to "procedural motor learning (in ms under placebo+ transcranial direct current stimulation". - Part III: objective: to examine the underlying neural mechanisms of levodopa-enhanced learning with functional magnetic resonance imaging. outcome measure: "increase in learning-related blood flow in the motor cortex after levodopa", compared to "increase in learning -related blood flow in the motor cortex after placebo";Primary end point(s): For the primary outcome measure, procedural motor learning performance (reaction times in ms) after levodopa-premedication, data will be submitted to an analysis of variance (ANOVA) with the factors CONDITION (placebo, levodopa) the factor GROUP (young healthy volunteer (HV), elderly HV, young stroke patient (SP), elderly SP) and the dependent variable test performance, followed by adequate post-hoc tests in the case of significance

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026