Neuromodulation in Depressed and Schizophrenic Patients - Changing MEP (Muscle Evoked Potentials) by tDCS (Transcranial Direct Current Stimulation)
Transcranial Direct Current Stimulation (tDCS)-Boosted Changes in Muscle Evoked Potentials (MEP) in Depressed and Schizophrenic Patients Reveal Deficits in Neuromodulation
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 23, 2010
CompletedFirst Posted
Study publicly available on registry
June 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedApril 22, 2011
April 1, 2011
1.2 years
June 23, 2010
April 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decreased MEP amplitudes in depressed patients
MEP amplitudes are supposed to be lower than in healthy controls or schizophrenic patients
at baseline
Secondary Outcomes (3)
Elevated MEP amplitudes in schizophrenic patients
at baseline
Normalization of MEP amplitudes after drug treatment
4 weeks after baseline
Normalization of MEP amplitudes after drug treatment
4 weeks after baseline
Eligibility Criteria
15 depressed patients 15 schizophrenic patients 15 healthy volunteers
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ludwig-Maximilians-University
Munich, 80333, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Frank Padberg, MD
Ludwig-Maximilian-University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 23, 2010
First Posted
June 25, 2010
Study Start
October 1, 2009
Primary Completion
December 1, 2010
Study Completion
January 1, 2011
Last Updated
April 22, 2011
Record last verified: 2011-04