Effect of Repetitive Transcranial Magnetic Stimulation on Resting State Brain Activity in Schizophrenia

Completed · Not applicable · Has a placebo group

Conditions studied: Schizophrenia

In brief

This study compares the efficacy of low and high frequency repetitive transcranial magnetic stimulation (rTMS) as a means of treating subjects with schizophrenia. Magnetic pulses delivered over the scalp cause brain activity. This activity has been shown to help decrease the intensity and frequency of auditory hallucinations (AH) in schizophrenia. The investigators will compare whether low or high frequencies work best. The investigators will also examine what changes occur in the brain that are related to improvement.

Key facts

Study ID

NCT01620086

Run by

University of Arkansas

People needed

26

Starts

2012-06-01

Expected to finish

2015-08-01

Last updated by the study team

2016-10-31

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Inclusion Criteria for schizophrenic subjects.
• Male and female patients, 21-65 years of age, of all races and ethnicities
• 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.
• Inclusion Criteria for control subjects.
• 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

You may not qualify if…

• Exclusion Criteria for schizophrenic subjects:
• 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
• Additional exclusion criteria for repetitive Transcranial Magnetic Stimulation (rTMS) include the following:
• 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
• Exclusion Criteria for control subjects:
• 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

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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