Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia

• Sponsor: Ludwig-Maximilians - University of Munich (Other)
• Overall Status: Completed
• CT.gov ID: NCT01378078
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Transcranial direct current stimulation (tDCS) showed beneficial effects on cognition in healthy subjects and depressed patients. In this study, patients with treatment resistant negative syndrome in schizophrenia will be treated with direct current stimulation. fMRI measures will be performed.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Device: eldith DC-stimulator (neuroconn, Ilmenau, Germany); Device: eldith DC-stimulator (Neuroconn, Ilmenau, Germany)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: sham patients receive sham tDCS stimulation	Device: eldith DC-stimulator (neuroconn, Ilmenau, Germany); daily tDCS treatment over left DLPFC, 20 min, 2 mA
Active Comparator: active active transcranial direct current stimulation	Device: eldith DC-stimulator (Neuroconn, Ilmenau, Germany); same as sham stimulation

Outcome Measures

Primary Outcome Measures

1. SANS reduction [4 weeks after baseline]

   decrease by 30%

Secondary Outcome Measures

1. neuropsychological tests [4 weeks after baseline]

   increase in SOPT by 30% increase in TMT by 30%

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• schizophrenic patients with a negative syndrome. PANSS > 40.

Exclusion Criteria:

• other psychiatric or neurologic diseases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik fuer Psychiatrie	Munich		Germany	80336

Sponsors and Collaborators

• Ludwig-Maximilians - University of Munich

Investigators

• Principal Investigator: Ulrich Palm, MD, Ludwig Maximilian University Munich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Keeser, Ph.D., Ludwig-Maximilians - University of Munich
• ClinicalTrials.gov Identifier: NCT01378078
• Other Study ID Numbers: 04/2011
• First Posted: Jun 22, 2011
• Last Update Posted: Jul 22, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Daniel Keeser, Ph.D., Ludwig-Maximilians - University of Munich: schizophrenia; negative syndrome; PANSS
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Jul 22, 2013