Effect of Repetitive Transcranial Magnetic Stimulation on Resting State Brain Activity in Schizophrenia
NCT ID: NCT01620086
Last Updated: 2016-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2012-06-30
2015-08-31
Brief Summary
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Detailed Description
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Tinnitus and AH in schizophrenia are prevalent and disabling disorders of sound perception. The investigators understanding of the precise mechanisms of these disorders is lacking. Interestingly, the symptoms of both disorders respond positively to rTMS of the temporal cortex in ways that defy contemporary understanding of the nature of these symptoms and of how rTMS should work to improve them. For example, phantom sound perception in both tinnitus and schizophrenia are linked to maladaptive, hyperactivity of auditory processing regions of temporal cortex; however, it is increasingly clear that these pathological changes alone are insufficient to explain the pronounced intrusiveness and negative emotional valance of symptoms in each disorder. Therefore, a barrier to understanding these disorders lies in understanding how changes in auditory cortex are synchronized with changes in other cortical regions that regulate perception and emotion. Additionally, at present, the decision of which rTMS frequency to apply as a treatment for phantom sound perception has no firm theoretical or empirical basis. Whereas, low frequency rTMS has traditionally been used, based upon contemporary models, to "inhibit" hyperactivity in auditory cortex; high frequency rTMS, which should induce an opposite effect on neuronal processing, not only works to improve symptoms but may be more effective for some subjects than low frequency rTMS. Therefore, contemporary models designed to explain how the frequency of rTMS influences neuronal activity immediate following stimulation are insufficient to explain how low and high frequencies of rTMS can mitigate phantom sound perception for days, weeks and months following a single course of treatment.
Hypothesis. The investigators propose that phantom sound perception in schizophrenia result from an imbalance of excitatory and inhibitory neural process in auditory networks and from synchronized, maladaptive changes in linked brain regions that regulate perception and emotion. Treating auditory cortex with repetitive, external magnetic stimulation can decrease phantom sound perception and distress by reversing the maladaptive brain reorganization that is set in motion by these underlying neural imbalances.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Patients
Patients with Schizophrenia who meet entry criteria for the study and first receive active repetitive transcranial magnetic stimulation for four days over a control site located at the vertex and then are randomized to receive repetitive Transcranial Magnetic Stimulation for four days over the temporal cortex at both 1 Hz and 10 Hz.
Active Repetitive Transcranial Magnetic Stimulation 1 Hz
active rTMS delivered at 1Hz frequency over temporal cortex
Active Repetitive Transcranial Magnetic Stimulation 10 Hz
active rTMS delivered at 10 Hz frequency over temporal cortex
Active control site Repetitive Transcranial Magnetic Stimulation at 1Hz
active rTMS delivered at either 1 Hz frequency over the vertex
Active control site Repetitive Transcranial Magnetic Stimulation at 10 Hz
Active 10 Hz rTMS delivered over the vertex
Controls
These subjects are normal controls without schizophrenia who receive sham, repetitive transcranial magnetic stimulation at 1 Hz for two days and then receive active, repetitive Transcranial Magnetic stimulation for two days. All stimulation is delivered at the control site located over the vertex.
Active control site Repetitive Transcranial Magnetic Stimulation at 1Hz
active rTMS delivered at either 1 Hz frequency over the vertex
Sham control site Repetitive Transcranial Magnetic Stimulation
sham rTMS delivered at 1Hz frequency over the vertex
Interventions
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Active Repetitive Transcranial Magnetic Stimulation 1 Hz
active rTMS delivered at 1Hz frequency over temporal cortex
Active Repetitive Transcranial Magnetic Stimulation 10 Hz
active rTMS delivered at 10 Hz frequency over temporal cortex
Active control site Repetitive Transcranial Magnetic Stimulation at 1Hz
active rTMS delivered at either 1 Hz frequency over the vertex
Sham control site Repetitive Transcranial Magnetic Stimulation
sham rTMS delivered at 1Hz frequency over the vertex
Active control site Repetitive Transcranial Magnetic Stimulation at 10 Hz
Active 10 Hz rTMS delivered over the vertex
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of auditory hallucinations (AH) associated with schizophrenia (verified at screening)
* Must report experiencing the presence of their phantom auditory perception for at least 6 months
* Female Subjects of childbearing age must take a pregnancy test to rule out pregnancy prior to participating in this study and during the study.
* Willing to provide informed consent to participate in all study interventions and assessments
* Subjects must have the capacity to sign and informed consent or a legal authorized representative (LAR) must sign in addition to the subject.
* Male and female patients, 21-65 years of age, of all races and ethnicities
* Willing to provide informed consent to participate in all study interventions and assessments
Exclusion Criteria
* Claustrophobia, or the inability to lie still in a confined space
* a personal or family history of epilepsy;
* a personal history of head injury, aneurysm, stroke, previous cranial neurosurgery, neurological or psychiatric disorders other than schizophrenia, or migraines
* recent use of cocaine or alcohol
* metal implants in the head or neck
* a pacemaker
* pregnancy (or the possibility of pregnancy)
* medications that lower seizure threshold (tricyclic antidepressants or bupropion) or reduce cortical excitation (anticonvulsants or benzodiazepines).
* Persons under 21 years of age (children) are excluded because the effect of rTMS on children is unknown, in contrast to adults, who have been well studied.
* Exclusion items specific to Functional Magnetic Resonance Imaging (fMRI):
* magnetic metallic implants
* electronic or magnetic implants, such as pacemakers, as these may stop working
* nonremovable dental implants
* permanent makeup or tattoos with metallic dyes
* a positive pregnancy test (for females)
* a self-reported history of loss of consciousness greater than 10 minutes
* physical disabilities that prohibit task performance
* Any other condition that the investigator believes might put the participant at risk
* Subjects with significant neurological disease, acoustic neuromas or glomus tumors, or other contraindicated neuropathology.
* Claustrophobia, or the inability to lie still in a confined space
* Magnetic metallic implants
* Electronic or magnetic implants, such as pacemakers, as these may stop working
* Nonremovable dental implants
* Permanent makeup or tattoos with metallic dyes
* A positive pregnancy test (for females)
* A self-reported history of loss of consciousness greater than 10 minutes
* Physical disabilities that prohibit task performance
* Any other condition that the investigator believes might put the participant at risk
21 Years
65 Years
ALL
Yes
Sponsors
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University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Erick Messias, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Countries
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Other Identifiers
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134662
Identifier Type: -
Identifier Source: org_study_id