Trial document





This trial has been registered retrospectively.
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  DRKS00004653

Trial Description

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Title

Influence of 10 Hz rTMS and noradrenergic modulation on motor learning in healthy humans

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Aim of our study is to investigate motor learning and its associated mechanisms in the brain. Furthermore, we want to know the role of a specific neurotransmitter called norepinephrine. We can do this by applying a Atomoxetine which is used in the treatment of ADHD (attention-deficit-hyperactivity-disorder). With a better understanding of the underlying mechanisms of learning and reorganization, we can optimize treatment strategies for subjects with neurological deficits after stroke and / or traumatic brain injuries in future.
This study will be conducted only in the BG-University Hospital Bergmannsheil Bochum, and about 50 people will participate. First, in all subjects, a determination of handedness is conducted by a questionnaire. Thereafter,we will investigate the brain area that controls hand muscle by means of magnetic stimulation. A group of volunteers once will receive a capsule of the medicament in a conventional dosage atomoxetine (60 mg), and the other group a capsule without active ingredient. At the time of implementation, the subjects do not know whether they have received the capsule with or without the drug. 1 and 2 hours after taking the medication, we will collect a blood sample to determine the level of the drug. A second measurement with the magnetic coil will follow next. Then, a motor exercise and repetitive magnetic stimulation over ‚Äčthe brain will be performed. A seven-digit sequence of numbers, namely the combination of “1 2 3 4 1 2 3” will be presented on the monitor for 40 seconds. Subjects will be instructed to repeatedly push the four numbered buttons of the response box as accurately and quickly as possible using their left hand (one task block). Each button relates to one finger (no. 1 to the index finger, no. 2 to the middle finger, no. 3 to the ring finger, and no. 4 to the little finger). During the first 2 seconds of one tapping block, one half of the subjects recieved 20 pulses of real-10Hz rTMS, one half recieved sham-rTMS. The motor task required the repetition of eight identical task blocks with pauses of 28 seconds interleaved. Within each task block, motor practice was preceded by repeptitive magnetic impulse application. Before starting the entire motor task, subjects will be allowed to perform two blocks of practice to familiarize themselves with the equipment and experimental procedure. In this case, we will use a different combination of numbers. After the 10-minute, measurements with the magnetic coil will be performed again.
The study takes about 3 hours.




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Brief Summary in Scientific Language

Aim of this study is to investigate the influence of transcranial magnetic stimulation and the role of the noradrenergic transmitter system on motor learning in healthy subjects. We use a fingertapping task as psychophysiological parameter. For excitability measurements, we use single pulse and paired pulse TMS parameters and techniques. Our scientific interests and questions are:
What is the influence of a high frequency rTMS protocoll on a fingertapping task in healthy humans?
What is the influence of a noradrenergic modulation on motor learning?
What is influence of both interventions on corticospinal and corticocortical excitability parameters?
Is there a correlation between motor learning and excitability parameters?

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Organizational Data

  •   DRKS00004653
  •   2013/01/16
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  •   yes
  •   Approved
  •   4317-12, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   Healthy subjects
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Interventions/Observational Groups

  •   Atomoxetine + real-10Hz-rTMS (single dose of 60 mg Atomoxetine per os)
  •   Placebo + real-10Hz-rTMS
  •   Atomoxetine + sham-rTMS (single dose of 60 mg Atomoxetine per os)
  •   Placebo + sham-rTMS
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Assessment of motor potentials evoked by transcranial magnetic stimulation, potentials were recorded with surface EMG-electrodes from the first dorsal interosseus muscle of the left hand (peak-to-peak-amplitudes in mV):
resting motor threshold, short-intracortical-inhibition, intracortical facilitation, stimulus response curve

Measured by the raw data of the fingertapping task:
target score (total number of correct responses), execution time (time required to the subsequent correct response in ms)

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/05/28
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   45   Years
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Additional Inclusion Criteria

healthy subjects,
right handed,
age between 18 - 45 years

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Exclusion Criteria

left-handed,
neurological diseases,
psychiatric diseases,
other medical diseases,
brain injury,
stroke,
febrile seizures in the childhood,
psychotropic medication,
fine motor skills,
implanted devices like cardiac pacemaker,
any metal in the head,
pregnancy,
lactation

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
    • Mr.  Priv.-Doz. Dr. med.  Peter  Schwenkreis 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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    • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
    • Mr.  Dr. med.  Matthias  Sczesny-Kaiser 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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    • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
    • Mr.  Dr. med.  Matthias  Sczesny-Kaiser 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Forschungsförderung der Ruhr-Universität Bochum, Medizinische Fakultät
    • Ms.  Dipl. Biol.  Irmgard  Borg 
    • Universitätsstraße 150
    • 44801  Bochum
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/10/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.