Schizophrenia Clinical Trial
Official title:
Boost rTMS for AVH - Therapeutic Response and Neurobiological Prediction Markers in Auditory Verbal Hallucinations
Verified date | April 2021 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, placebo controlled, double-blind clinical trial. The investigators aim to examine the safety and efficacy of repeated transcranial magnetic stimulation (rTMS) for the treatment of auditory verbal hallucinations (AVH) in patients with schizophrenia who are not taking antipsychotic medication. The investigators employ a novel, accelerated protocol with only four sessions of low-frequency rTMS in one day. The effects of this accelerated protocol will be compared to the sham stimulation. Additionally, the investigators will examine the effects of rTMS on a neurophysiological level by evaluating mechanism of action in the temporo-parietal lobe by means of functional magnetic resonance imaging.
Status | Terminated |
Enrollment | 5 |
Est. completion date | January 22, 2019 |
Est. primary completion date | January 22, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 to 65 4. Diagnosed with Diagnostic and Statistical Manual (DSM) V diagnosis of schizophrenia (295.90), schizoaffective disorder (295.70), or brief psychotic disorder (298.80), prone to AVH in the acute phases of the disorder 5. Willing to adhere to the rTMS regimen 6. No antipsychotic medication in the last two weeks prior to the start of the study as well as no antipsychotic medication during participation in the study 7. Agreement to adhere to Lifestyle Considerations throughout study duration Exclusion Criteria: 1. Current use of antipsychotic medication within the last 2 weeks 2. Electroconvulsive therapy or rTMS within three months (see the TMS screening questionnaire) 3. History of seizures 4. Presence of implanted electronic device or metal implant in the head and neck region (DBS, cochlear implant, etc.) 5. Pregnancy, as assessed with a pregnancy test prior to every MRI measurement, or lactation 6. Any active general medical condition or central nervous system disease which can affect cognition or response to treatment 7. Treatment with another investigational drug or other intervention within 2 weeks 8. Current diagnosis of delirium, dementia, or amnestic amnesiac disorder; Diagnosis of mental retardation; Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week as indicated by self-report. 9. Patients who are cognitively impaired and are thus not able to give informed consent |
Country | Name | City | State |
---|---|---|---|
United States | The Zucker Hillside Hospital, Northwell Health | Manhasset | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations Assessed With the Hallucination Change Scale | Examine change in AVH severity, measured with the Hallucination Change Scale, due to low-frequency rTMS.
The Hallucination Change Scale is a self-rating assesses severity of hallucinations. It is anchored at baseline using the patient's description of AVH for the previous 24-hours which is assigned a score of 10. The subsequent assessments are in relation to the baseline where a reduction of AVH relates to a value < 10 (best being a value of 0) and a worsening of AVH relates to a value > 10 (twice as severe as baseline being a value of 20). |
Four timepoints of the Hallucination Change Scale (after every TMS session). Here, score after final session is reported. |
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