Clinical trial NCT01150734: Neuromodulation in Depressed and Schizophrenic Patients - Changing MEP (Muscle Evoked Potentials) by tDCS (Transcranial Direct Current Stimulation)
Official title: Transcranial Direct Current Stimulation (tDCS)-Boosted Changes in Muscle Evoked Potentials (MEP) in Depressed and Schizophrenic Patients Reveal Deficits in Neuromodulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Depression
Keywords: differences of Muscle evoked potentials (MEP) in psychiatric illnesses
differences in neuromodulation
normalization of neuromodulation after pharmacological treatment
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2010-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 15 depressed patients 15 schizophrenic patients 15 healthy volunteers

Brief summary: Muscle evoked potentials (MEP) are supposed to different in schizophrenic and depressed patients, compared to a sample of healthy volunteers. Transcranial Magnetic Stimulation (TMS)-evoked MEP are measured in all three groups at baseline and after tDCS (2 mA, 20 minutes). MEP amplitudes are supposed to normalize quickly in healthy volunteers, to stay diminished in depressed patients and to stay elevated in schizophrenic patients. These differences should disappear after regular pharmacological treatment. Outcome measures will be done in week 2 and week 4.


Eligibility criteria: Inclusion Criteria:

* The patient must be in the condition to understand the patient-information, as well as the necessary examinations.
* He/she must be able to give a written consent.
* No medication at least three weeks before enrollment.

Exclusion Criteria:

* Existence of a care/legal incapacity
* Existing pregnancy
* Severe psychiatric illness (with exception of affective disorder)
* Acute suicidality
* Drug-, medication- or alcohol dependence
* Dementia according to DSM IV / ICD 10-criterions
* Severe brain infarctus in the anamnesis
* Indications of structural damage of the basal ganglia or the brain stem
* Severe neurological disorders (e.g. M. Parkinson, epilepsy, discus-prolapse, dementia, systemic neurological illnesses, normal pressure hydrocephalus, cerebrovascular diseases, elevated intracranial pressure, in the last 6 months, polyneuropathies).
* Severe other medical conditions, like manifest arterial hypertonia, severe heart disease, pacemakers, respiratory failure, malignant illnesses all type, also in the history, active infectious diseases, skeletal disorders (like M. Paget, osteoporosis with spontaneous fractures, fresh fractures) Other circumstances, that speaks against a participation of the patient pinion of Medical Doctor at this study.

Primary outcomes:
measure: Decreased MEP amplitudes in depressed patients
timeFrame: at baseline
Secondary outcomes:
measure: Elevated MEP amplitudes in schizophrenic patients
timeFrame: at baseline
measure: Normalization of MEP amplitudes after drug treatment
timeFrame: 4 weeks after baseline
measure: Normalization of MEP amplitudes after drug treatment
timeFrame: 4 weeks after baseline
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig-Maximilians-University
Study officials:
affiliation: Ludwig-Maximilian-University
name: Frank Padberg, MD
role: STUDY_DIRECTOR
References: