Non-Invasive Brain Stimulation for Medication-Resistant Auditory Hallucinations in Schizophrenia Patients

NCT02240446 | Withdrawn DMC

• 2 other identifiers: 1406M51762IEM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel neuromodulation approaches using transcranial direct current stimulation (tDCS) for treating schizophrenia patients with medication-resistant auditory hallucinations. The investigators will use tDCS to stimulate prefrontal cortex. TDCS is a non-invasive brain stimulation technique that can modulate brain connectivity. Non-invasive brain neuromodulation will be combined (paired-neuromodulation) with training of a task that requires top-down control of auditory processes. Paired-neuromodulation can potentially be used as a therapeutic intervention to decrease auditory hallucinations in schizophrenia.

Conditions

Auditory Hallucinations; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale

  Scores from this scale will show severity of auditory hallucinations. We will assess CHANGE in scores between each time-point described in the Time Frame.

  pre-intervention, post-intervention (after five consecutive days of tDCS intervention), 3,6, and 9 months after post-intervention

Secondary Outcomes (1)

• Auditory Hallucination Rating Scale

  pre-intervention, post-intervention (after five consecutive days of tDCS intervention), 3, 6, and 9 months after post-intervention

Other Outcomes (1)

• Dichotic listening task performance

  Will be assessed twice a day for five consecutive days

Study Arms (2)

Active tDCS

EXPERIMENTAL

Active tDCS

Device: Active tDCS

Sham tDCS

PLACEBO COMPARATOR

Sham tDCS

Device: Sham tDCS

Interventions

Active tDCS DEVICE

2mA stimulation for 20 minutes twice a day for five consecutive days

Active tDCS

Sham tDCS DEVICE

2mA for 30 seconds twice a day for five consecutive days

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Current DSM-V-defined diagnosis of SZ or Schizoaffective Disorder as assessed by the Structured Clinical Interview for Axis I DSM-V Disorders (SCID-I/P)
• Ages 18-45
• Competent and willing to sign consent form

You may not qualify if:

• Any serious neurological or endocrine disorder or any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness of more than 30 min, HIV)
• Diagnostic and Statistics Manual (DSM-V) criteria for mental retardation or axis I psychiatric disorder, subjects may have a lifetime but not current diagnosis of depression
• Medical condition which requires treatment with a medication with psychotropic effects
• Significant risk of suicidal or homicidal behavior
• Documented loss of consciousness (LOC) for longer than 30 minutes or LOC with neurological sequelae
• History of electro-convulsive therapy
• Pregnancy

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (4)

• 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.

  PMID: 22581236 BACKGROUND

• Hugdahl K, Nygard M, Falkenberg LE, Kompus K, Westerhausen R, Kroken R, Johnsen E, Loberg EM. Failure of attention focus and cognitive control in schizophrenia patients with auditory verbal hallucinations: evidence from dichotic listening. Schizophr Res. 2013 Jul;147(2-3):301-9. doi: 10.1016/j.schres.2013.04.005. Epub 2013 May 9.

  PMID: 23664588 BACKGROUND

• Lawrie SM, Buechel C, Whalley HC, Frith CD, Friston KJ, Johnstone EC. Reduced frontotemporal functional connectivity in schizophrenia associated with auditory hallucinations. Biol Psychiatry. 2002 Jun 15;51(12):1008-11. doi: 10.1016/s0006-3223(02)01316-1.

  PMID: 12062886 BACKGROUND

• Thomsen T, Rimol LM, Ersland L, Hugdahl K. Dichotic listening reveals functional specificity in prefrontal cortex: an fMRI study. Neuroimage. 2004 Jan;21(1):211-8. doi: 10.1016/j.neuroimage.2003.08.039.

  PMID: 14741658 BACKGROUND

MeSH Terms

Conditions

Hallucinations; Schizophrenia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Jazmin Camchong, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Kelvin O Lim, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 15, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

US (1)