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Neuromodulation in Depressed and Schizophrenic Patients - Changing MEP (Muscle Evoked Potentials) by tDCS (Transcranial Direct Current Stimulation)

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ClinicalTrials.gov Identifier: NCT01150734
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : April 22, 2011
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich

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.

Condition or disease
Schizophrenia Depression

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transcranial Direct Current Stimulation (tDCS)-Boosted Changes in Muscle Evoked Potentials (MEP) in Depressed and Schizophrenic Patients Reveal Deficits in Neuromodulation
Study Start Date : October 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Decreased MEP amplitudes in depressed patients [ Time Frame: at baseline ]
    MEP amplitudes are supposed to be lower than in healthy controls or schizophrenic patients


Secondary Outcome Measures :
  1. Elevated MEP amplitudes in schizophrenic patients [ Time Frame: at baseline ]
    MEP amplitued are supposed to be elevated in schizophrenic patients in comparison to depressed patients or healthy controls

  2. Normalization of MEP amplitudes after drug treatment [ Time Frame: 4 weeks after baseline ]
    MEP aplitued of schizophrenic patients are supposed to normalize after regular drug treatment within 4 weeks.

  3. Normalization of MEP amplitudes after drug treatment [ Time Frame: 4 weeks after baseline ]
    MEP aplitued of depressed patients are supposed to normalize after regular drug treatment within 4 weeks.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
15 depressed patients 15 schizophrenic patients 15 healthy volunteers
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150734


Locations
Germany
Ludwig-Maximilians-University
Munich, Germany, 80333
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Study Director: Frank Padberg, MD Ludwig-Maximilian-University

Responsible Party: Palm, U, MD, Dept. of Psychiatry and Psychotherapy
ClinicalTrials.gov Identifier: NCT01150734     History of Changes
Other Study ID Numbers: 07/2009
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: April 22, 2011
Last Verified: April 2011

Keywords provided by Ludwig-Maximilians - University of Munich:
differences of Muscle evoked potentials (MEP) in psychiatric illnesses
differences in neuromodulation
normalization of neuromodulation after pharmacological treatment

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders