NCT01801787

Brief Summary

The current study investigates the basic principles that underlie the efficacy of transcranial direct current stimulation for chronic auditory verbal hallucinations in schizophrenia in a multimodal design.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

February 26, 2013

Last Update Submit

August 13, 2016

Conditions

Auditory Verbal HallucinationsSchizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change of Auditory Hallucination Rating Scale score

    Auditory Hallucination Rating Scale score will be assessed at baseline; changes thereof at 3 days after intervention and 3 months after intervention are primary outcome measures

    baseline; 3 days after intervention; 3 months after intervention

Secondary Outcomes (1)

  • Positive And Negative Syndrome Scale

    baseline; 3 days after intervention; 3 months after intervention

Other Outcomes (3)

  • N1 suppression during talking and listening

    baseline; 3 days after intervention

  • Diffusion Tensor Imaging: Fractional anisotropy of longitudinal superior fascicle and arcuate fascicle

    baseline; 3 days after intervention

  • Default Mode Network connectivity

    baseline; 3 days after intervention

Study Arms (2)

verum tDCS

EXPERIMENTAL

left-hemispheric tDCS: anode placed midway between F3 and FP1, cathode placed midway between T3 and P3

Device: tDCS

sham tDCS

SHAM COMPARATOR

left-hemispheric sham tDCS: anode placed midway between F3 and FP1, cathode placed midway between T3 and P3

Device: tDCS

Interventions

tDCSDEVICE

active vs. sham tDCS left hemisphere

Also known as: device: neuroConn tDCS PLUS device
sham tDCSverum tDCS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of schizophrenia
  • chronic auditory verbal hallucinations
  • right-handed

You may not qualify if:

  • drug abuse other than nicotine
  • severe cognitive deficits
  • severe medical conditions
  • severe neurological disorders
  • severe microangiopathy
  • history of electroconvulsive therapy
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charité University Medicine

Berlin, 10117, Germany

Location

Charité University Medicine

Berlin, 12203, Germany

Location

MeSH Terms

Conditions

HallucinationsSchizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Robert Lindenberg, MD

    Department of Neurology, Charité University Medicine Berlin

    PRINCIPAL INVESTIGATOR

  • Andres H. Neuhaus, MD

    Department of Psychiatry, Charité University Medicine Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 26, 2013

First Posted

March 1, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

DE(2)