|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
German Clinical Trials Register |
|
Last refreshed on:
|
8 April 2024 |
|
Main ID: |
DRKS00011665 |
|
Date of registration:
|
30/01/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Parameter-based evaluation of attentional impairments in schizophrenia and their modulation by prefrontal transcranial direct current stimulation: a randomized, double-blind, sham-controlled study
|
|
Scientific title:
|
Parameter-based evaluation of attentional impairments in schizophrenia and their modulation by prefrontal transcranial direct current stimulation: a randomized, double-blind, sham-controlled study
|
|
Date of first enrolment:
|
01/05/2015 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Complete |
|
URL:
|
http://drks.de/search/en/trial/DRKS00011665 |
|
Study type:
|
interventional |
|
Study design:
|
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: parallel; Study design purpose: basic science
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Alkomiet
Hasan |
|
Address:
|
Nußbaumstr. 7
80336
München
Germany |
|
Telephone:
|
0894400 55536 |
|
Email:
|
Alkomiet.Hasan@med.uni-muenchen.de |
|
Affiliation:
|
Klinik für Psychiatrie und Psychotherapie Klinikum der Universität München |
|
|
Name:
|
Nadine
Gögler |
|
Address:
|
Leopoldstr. 13
80802
München
Germany |
|
Telephone:
|
089218072537 |
|
Email:
|
nadine.goegler@psy.lmu.de |
|
Affiliation:
|
Institut für Psychologie Ludwig-Maximilians-Universität München |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Age: 20-50 years; IQ > 85; Diagnosis: ICD-10 F20.0; F25.0; normal or corrected to normal vision (no red-green color blindness)
Exclusion criteria: Epileptic seizures, pregnancy, metallic foreign body implants; pace maker; pregnancy; acute suicidal intent;
Age minimum:
20 Years
Age maximum:
50 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Schizophrenia
|
F20
F25
|
|
Schizoaffective disorders
|
|
Intervention(s)
|
Group 1: active tDCS 2mA 20 minutes; Anode: F3; Cathode: FP2; single-session tDCS
Group 2: sham tDCS 20 minutes; Anode: F3; Cathode: FP2; single-session tDCS
|
|
Primary Outcome(s)
|
|
Directly after and 24h after stimulation; completion of rating instrument: parametric attentional assessment based on Bundesen’s Theory of Visual Attention (TVA; Bundesen, 1990). (The assessed attentional parameters are: processing speed, visual short-term memory capacity, top-down control)
|
|
Secondary Outcome(s)
|
|
Directly after stimulation: completion of Comfort Rating Scale (CRQ) to prove that the application had been running smoothly.
|
|
Source(s) of Monetary Support
|
|
German Center for Brain Stimulation (GCBS) research consortium
|
|
European Union FP7 Marie Curie ITN Grant (INDIREA)
|
|
Ethics review
|
Status: Approved
Approval date: 19/03/2015
Contact:
ethikkommission@med.uni-muenchen.de
Ethikkommission der Med. Fakultät der LMU
+49-89-440055191
ethikkommission@med.uni-muenchen.de
|
|