Clinical Trial: Non-Invasive Brain Stimulation for Medication-Resistant Auditory Hallucinations in Schizophrenia Patients
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Non-Invasive Brain Stimulation for Clinical Intervention for Medication-Resistant Auditory Hallucinations in Schizophrenia Patients
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.
Detailed Summary:
25% of schizophrenia (SZ) patients report chronic auditory hallucinations (AH) despite being on medication. Previous research proposed that hyperactivity of the left temporo-parietal cortex (11) and hypoactivity in left dorsolateral prefrontal cortex (DLPFC) (12) are associated with the onset of AH. While temporal cortex hyperactivity has been extensively manipulated with neuromodulation interventions trying to reduce AH, results have not been consistent (1,13). Recent transcranial direct current stimulation (tDCS) work that targeted both regions above by applying excitatory stimulation over the left DLPFC and inhibitory stimulation on the left temporo-parietal cortex reported a 30% reduction in AH in patients with medication refractory AH that lasted up to 3 months after treatment (14). The investigators are interested to further investigate whether the use of paired neuromodulation (P-NM) with tDCS in co-targeting top-down executive control with bottom-up sensory processes would result in a larger reduction in AH. To date, there are no studies that have used P-NM to examine the magnitude of plasticity of executive control on sensory processing in SZ patients. This type of P-NM would be relevant since AH are thought to be the result of a lack of top-down control over perceptual distortions of internally generated speech. In the forced-attention dichotic listening task (DL), two different syllables are simultaneously presented to the left and the right ear. Subjects are required to pay attention to and report either the left or right ear stimulus. Due to the preponderance of the contralateral pathways, the right ear syllable is projected to the left temporal lobe for processing, while the left ear stimulus is projected to the right temporal lobe and has to be transferred across the corpus callosum to be processed in the left hemisphere. Healthy controls show a right ear advantage (REA) while SZ patients do not (15). DL t
Sponsor: University of Minnesota - Clinical and Translational Science Institute
Current Primary Outcome: Positive and Negative Syndrome Scale [ Time Frame: pre-intervention, post-intervention (after five consecutive days of tDCS intervention), 3,6, and 9 months after post-intervention ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Auditory Hallucination Rating Scale [ Time Frame: pre-intervention, post-intervention (after five consecutive days of tDCS intervention), 3, 6, and 9 months after post-intervention ]
Original Secondary Outcome: Same as current
Information By: University of Minnesota - Clinical and Translational Science Institute
Dates:
Date Received: September 9, 2014
Date Started: June 2013
Date Completion: December 2018
Last Updated: July 18, 2016
Last Verified: July 2016
