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Completed

NCT Number: NCT01150734

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ludwig-Maximilians-University

Munich, 80333, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

Transcranial Direct Current Stimulation (tDCS)-Boosted Changes in Muscle Evoked Potentials (MEP) in Depressed and Schizophrenic Patients Reveal Deficits in Neuromodulation

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jun 25, 2010
Registry last updated
Apr 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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