Depression Clinical Trial
— rTMS-P50Official title:
Evaluation of Effect of Low and High-frequencies of Repetitive Transcranial Magnetic Stimulation (rTMS) by the Suppression of P50 Evoked Potential Component (rTMS-P50)
The repetitive transcranial magnetic stimulation (rTMS) is a recent technique that has
demonstrated its efficiency in both depression and schizophrenia. However if its efficiency
has been recognized by the scientific community and the clinicians, its action on neurons
and cerebral networks remains debated.
In the motor regions, the different rTMS studies generally use frequencies of stimulation of
1 to 40 Hz with differential effects; the low frequencies being associated with an
inhibitory effect whereas highest frequencies have rather some facilitator effects as
attested by the motor responses. What is valid for the motor system is not however
necessarily applicable to other cerebral regions that have different neuronal organizations.
If it is easy to observe these opposite effects of rTMS on the motor system (presence or
absence of movements), these potential effects on more integrated cortex involved in high
level functions have not been proved.
One of the possibilities to interpret the effects of the rTMS in no-motor cerebral regions
would be to study the modifications of the EEG before and after rTMS and to see if a
differential effect of the high and low frequencies of stimulation exists. Up to now, the
studies having coupled these two techniques have observed modifications of the brain
electric activity only during some seconds to minutes after rTMS, what appears in contrast
with the clinical effects observed after a long delay (several days).
The contribution of our research resides in the use of the paradigm of suppression of P50
evoked potential component before and after rTMS tested with low and high frequencies of
stimulation. This paradigm consists in two identical auditory stimuli presented at a very
short interval (generally 500 milliseconds), the second sound generating a P50 wave of
weaker amplitude than the first or being completely abolished in healthy subjects. However,
this effect that has been well studied could result from an inhibitory action due to the
gabaergic interneurons on the pyramidal neurons of the cortex. Thus, the investigators
hypothesize that high frequency rTMS would have a facilitator effect on temporal lobe and so
would induce no suppression of the P50 after-rTMS whereas low frequency rTMS would induce an
inhibitory effect marked by a greater suppression of the P50.
Methods: 30 healthy subjects (of which 16 women) will be included after written consent.
They will receive after randomization 2 sessions of rTMS in cross over at 1Hz and 20Hz at 30
days interval. An EEG and a P50 evoked potential will be done before and after rTMS. The
site of stimulation will be determined by neuronavigation and will correspond to the maximal
activation cluster generated by a language task during functional magnetic resonance
imaging. The main judgment criterion is the S2/S1 ratio of the P50. The potential secondary
effects will be evaluated (UKU adapted). The secondary criteria are the comparisons before
and after rTMS of EEG spectrums in the alpha, beta and gamma bands.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 2013 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - healthy subjects, right-handed, aged from 18 to 60 years - written consent - with social security Exclusion Criteria: - pregnancy, breastfeeding - brain tumor or epilepsy - psychiatric, neurological or ear-nose-throat disorders, current or past - healthy subjects with psychotropic drugs or with substance abuses - healthy subjects with tabacco weaning - protected major with tutor - counter-indication to MRI and rTMS |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
France | Caen University Hospital, department of psychiatry and explorations fonctionnelles neurologiques | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | P50 Ratio Stimulation 2/S stimulation 1 | day of stimulation (day 1) | No |
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