Effect of Repetitive Transcranial Magnetic Stimulation on Resting State Brain Activity in Schizophrenia
1 other identifier
interventional
26
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Jun 2012
Typical duration for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
October 26, 2016
CompletedOctober 31, 2016
October 1, 2016
3.2 years
June 4, 2012
July 25, 2016
October 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)"
Secondary Outcomes (2)
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).
change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"
Depression Level Changes as Measured by the Hamilton Depression Inventory (HAMD).
change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"
Study Arms (2)
Patients
EXPERIMENTALPatients 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.
Controls
EXPERIMENTALThese 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.
Interventions
active rTMS delivered at 1Hz frequency over temporal cortex
active rTMS delivered at 10 Hz frequency over temporal cortex
active rTMS delivered at either 1 Hz frequency over the vertex
sham rTMS delivered at 1Hz frequency over the vertex
Active 10 Hz rTMS delivered over the vertex
Eligibility Criteria
You may qualify if:
- 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.
- 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:
- 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
- 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.
- 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)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Erik Messias, MD
- Organization
- University of Arkansas for Medical Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Erick Messias, MD, MPH, PhD
University of Arkansas
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 15, 2012
Study Start
June 1, 2012
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
October 31, 2016
Results First Posted
October 26, 2016
Record last verified: 2016-10