tDCS & Auditory Hallucinations in Schizophrenia

Schizophrenia Clinical Trial

Official title:

tDCS & Auditory Hallucinations in Schizophrenia (AVH-SZ)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02227563
• Other study ID #: Meiron 2013-3
• Status: Terminated
• Phase: N/A
• First received: May 20, 2014
• Last updated: November 1, 2016
• Start date: March 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Herzog Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Helsinki IRBIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral prefrontal cortex.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Ages 18-60

• Primary diagnosis of Diagnostic and Statistical Manual, fifth edition, schizophrenia

• Persistent auditory verbal hallucinations

• Right handed

• Under stable doses of antipsychotic medication for =4 weeks

• Normal hearing by self-report and physical exam

• Use of effective method of birth control for women of childbearing capacity

• Capable to provide informed consent. For patients judged to be incapable to provide informed consent the legal guardian of the patient must agree to participation in the study and provide signed informed consent

Exclusion Criteria:

• Current or past history of substance dependence or abuse (excluding nicotine)

• Other current Axis I disorders

• History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)

• Frequent and persistent migraines

• History of adverse reaction to neurostimulation

• Participation in study of investigational medication within 6 weeks

• Pregnancy

• Women who are breast-feeding

• Current significant laboratory abnormality

Study Design

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

Related Conditions & MeSH terms

• Hallucinations
• Schizophrenia

Intervention

Device:
• Active tDCS
repetitive daily tDCS sessions for a period of one week
• control

Locations

Country	Name	City	State
Israel	Herzog Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Herzog Hospital

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091. Erratum in: Am J Psychiatry. 2012 Dec 1;169(12):1321. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change from baseline in auditory event related potentials (ERP)		change in auditory ERP from baseline at 1 week	No
Primary	change from baseline in auditory hallucination rating scale		1 week post-treatment	No
Secondary	change in self-report quality of life scale from baseline		1 week post treatment	No