Schizophrenia Clinical Trial
Official title:
Effect of Repetitive Transcranial Magnetic Stimulation (RTMS) on Resting State Brain Activity in Schizophrenia
Verified date | October 2016 |
Source | University of Arkansas |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Auditory Hallucinations Questionnaire (AHQ). | The Auditory Hallucinations Questionnaire (AHQ) will be used to determine the patient's perceptions of change in auditory hallucinations(s). Normal controls do not fill out this measure because they do not have auditory hallucinations. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured. The range of scores is 0-70, higher scores mean more symptoms. | change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)" | No |
Secondary | Overall Change in the Percent Habituation of the P50 Evoked Response Potential at 250 Inter Stimulus Interval (ISI) Between the Control and Active Treatments (1 and 10 Hz). | Percent habituation refers to change in the amplitude of the P50 evoked response potential following a 250 ms inter stimulus interval. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured. | change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)" | No |
Secondary | Depression Level Changes as Measured by the Hamilton Depression Inventory (HAMD). | HAM-D is a multiple choice questionnaire that clinicians administer to rate the severity of a subject's depression. There are 17 questions; each question has between 3-5 possible responses which increase in severity (range 0 to 52). The clinician chooses the correct response by interviewing the subject and by observing the symptoms. A score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured. | change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)" | No |
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