Non-invasive Brain Stimulation for Auditory Verbal Hallucinations in Schizophrenia

Schizophrenia Clinical Trial

Official title:

The Mechanism of Non-invasive Brain Stimulation for Therapy of Chronic Auditory Verbal Hallucinations in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801787
• Other study ID #: EA4/123/12
• Status: Completed
• Phase: N/A
• First received: February 26, 2013
• Last updated: August 13, 2016
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• diagnosis of schizophrenia

• chronic auditory verbal hallucinations

• right-handed

Exclusion Criteria:

• drug abuse other than nicotine

• severe cognitive deficits

• severe medical conditions

• severe neurological disorders

• severe microangiopathy

• history of electroconvulsive therapy

• pregnancy or lactation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Auditory Verbal Hallucinations
• Hallucinations
• Schizophrenia

Intervention

Device:
• tDCS
active vs. sham tDCS left hemisphere

Locations

Country	Name	City	State
Germany	Charité University Medicine	Berlin
Germany	Charité University Medicine	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	N1 suppression during talking and listening	N1 suppression during talking and listening will be assessed at baseline; change thereof at 3 days after intervention is further outcome measure	baseline; 3 days after intervention	No
Other	Diffusion Tensor Imaging: Fractional anisotropy of longitudinal superior fascicle and arcuate fascicle	Fractional anisotropy of longitudinal superior fascicle and arcuate fascicle will be assessed at baseline; change thereof 3 days after intervention is further outcome measure	baseline; 3 days after intervention	No
Other	Default Mode Network connectivity	Default Mode Network connectivity will be assessed at baseline; change thereof 3 days after intervention is further outcome measure	baseline; 3 days after intervention	No
Primary	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	No
Secondary	Positive And Negative Syndrome Scale	Positive And Negative Syndrome Scale score will be assessed at baseline; changes thereof at 3 days after intervention and 3 months after intervention are secondary outcome measures	baseline; 3 days after intervention; 3 months after intervention	No