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Parameter-based evaluation of attentional impairments in schizophrenia and their modulation by prefrontal transcranial direct current stimulation: a randomized, double-blind, sham-controlled study

Organizational Data

DRKS-ID:
DRKS00011665
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2017-01-30
Last update in DRKS:
2017-01-30
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

Next to the disorder-related symptoms patients with schizophrenia often show severe cognitive deficits, particularly with respect to attentional functions (e.g. a reduced processing speed). A reduced excitability or abnormal activation patterns of frontal brain areas are suggested to underlie these cognitive symptoms. Transcranial direct current stimulation (tDCS) is a non-invasive, painless treatment option to normalize such abnormal brain activation patterns and potentially to restore cognitive/attentional functions. Therefore, in this study we want to investigate the specific attentional functions that are compromised in patients with schizophrenia and assess, in a second step, the potential of single-dose tDCS to improve these attentional deficits.

Brief summary in scientific language

Attentional and executive dysfunctions constitute core cognitive symptoms in schizophrenia. To some extent these dysfunctions remit, but some exist even beyond clinical remission. Abnormal activation patterns within fronto-parietal attention networks are discussed as the underlying source of these attentional impairments. Accordingly, modulation of intrinsic prefrontal networks through tDCS has recently been proposed as potential non-invasive and safe treatment option for the remediation of cognitive dysfunctions in schizophrenia patients. Therefore, this study was set out to explore whether the modulation of intrinsic networks by means of single-dose tDCS can have a functional significance for cognitive, and more specifically, visual attentional processes in schizophrenia.

Health condition or problem studied

ICD10:
F20 - Schizophrenia
ICD10:
F25 - Schizoaffective disorders
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
active tDCS 2mA 20 minutes; Anode: F3; Cathode: FP2; single-session tDCS
Arm 2:
sham tDCS 20 minutes; Anode: F3; Cathode: FP2; single-session tDCS

Endpoints

Primary outcome:
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:
Directly after stimulation: completion of Comfort Rating Scale (CRQ) to prove that the application had been running smoothly.

Study Design

Purpose:
Basic research/physiological study
Allocation:
Randomized controlled study
Control:
  • Placebo
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Assessor
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Universitätsklinikum LMU, Klinik für Psychiatrie und Psychotherapie München

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2015-05-01
Planned study completion date:
No Entry
Actual Study Completion Date:
2016-10-31
Target Sample Size:
20
Final Sample Size:
20

Inclusion Criteria

Sex:
All
Minimum Age:
20 Years
Maximum Age:
50 Years
Additional 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;

Addresses

Primary Sponsor

Klinik für Psychiatrie und Psychotherapie, Klinikum der Universität München
PD Dr. Alkomiet Hasan
Nußbaumstr. 7
81336 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Psychiatrie und Psychotherapie Klinikum der Universität München
PD Dr. Alkomiet Hasan
Nußbaumstr. 7
80336 München
Germany
Telephone:
0894400 55536
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Institut für Psychologie Ludwig-Maximilians-Universität München
Nadine Gögler
Leopoldstr. 13
80802 München
Germany
Telephone:
089218072537
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinik für Psychiatrie und Psychotherapie Klinikum der Universität München
PD Dr. Alkomiet Hasan
Nußbaumstr. 7
80336 München
Germany
Telephone:
0894400 55536
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

European Union FP7 Marie Curie ITN Grant (INDIREA)
South Parks Road
OX1 3UD Oxford
United Kingdom
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

German Center for Brain Stimulation (GCBS) research consortium
Nussbaumstraße 7
80336 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Med. Fakultät der LMU
Pettenkoferstraße 8
80336 München
Germany
Telephone:
+49-89-440055191
Fax:
+49-89-440055192
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2015-01-19
Ethics committee number:
054-15
Vote of the Ethics Committee:
Approved
Date of the vote:
2015-03-19

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
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UTN (Universal Trial Number):
No Entry
EUDAMED Number:
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IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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