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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150734
• Other study ID #: 07/2009
• Status: Completed
• Phase: N/A
• First received: June 23, 2010
• Last updated: April 21, 2011
• Start date: October 2009
• Est. completion date: January 2011

Study information

• Verified date: April 2011
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Schizophrenia

Locations

Country	Name	City	State
Germany	Ludwig-Maximilians-University	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased MEP amplitudes in depressed patients	MEP amplitudes are supposed to be lower than in healthy controls or schizophrenic patients	at baseline	No
Secondary	Elevated MEP amplitudes in schizophrenic patients	MEP amplitued are supposed to be elevated in schizophrenic patients in comparison to depressed patients or healthy controls	at baseline	No
Secondary	Normalization of MEP amplitudes after drug treatment	MEP aplitued of schizophrenic patients are supposed to normalize after regular drug treatment within 4 weeks.	4 weeks after baseline	No
Secondary	Normalization of MEP amplitudes after drug treatment	MEP aplitued of depressed patients are supposed to normalize after regular drug treatment within 4 weeks.	4 weeks after baseline	No