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New treatment option for Schizophrenia and Related Disorders
Official title Alternative Stimulation Mode and Location for Auditory Hallucination Neuromodulation Treatment
ClinicalTrials.gov ID: NCT02916810
What this study is testing
- What it's testing
- The purpose of the study is to test the hypothesis that functionally navigated repetitive TMS stimulations to the prefrontal cortex (PFC) modulate aberrant cortical electrical activities at PFC circuitry. The TMS location of the PFC site will be individually localized by the symptom-related functional connectivity between PFC and symptom related areas (such as the auditory and language processing cortex).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- Male and female ages between ages 18-50 years
- Ability to give written informed consent (age 18 or above)
- Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.
- Is currently under the care of a licensed primary care provider or mental healthcare provider (e.g., psychiatrist, psychologist, nurse practitioner...
- Have auditory hallucinations despite treated by two or more antipsychotics including one atypical antipsychotic medication.
You likely can't join if
- Persons with a first-degree relative with inherited epilepsy, seizure disorder, or seizures or persons who answer "yes" to any of the parts (A. - G.)...
- Taking \> 400 mg clozapine/day and not on anti-seizure medication(s) with sufficient dose.
- Failed TMS screening questionnaire.
- Significant alcohol or other drug use (substance abuse within 1 month or substance dependence history within 6 months and having substance usage...
- Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, CNS infection...
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm...
See the full eligibility criteria
- Male and female ages between ages 18-50 years
- Ability to give written informed consent (age 18 or above)
- Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.
- Is currently under the care of a licensed primary care provider or mental healthcare provider (e.g., psychiatrist, psychologist, nurse practitioner, licensed clinical social worker).
- Have auditory hallucinations despite treated by two or more antipsychotics including one atypical antipsychotic medication.
- Agrees to: (a) provide written permission, as requested, to allow any and all forms of communication between the investigators and study staff and any health care provider who currently provides and/or has provided...
- Persons with a first-degree relative with inherited epilepsy, seizure disorder, or seizures or persons who answer "yes" to any of the parts (A. - G.) of Question 3 of an epilepsy screening questionnaire.
- Taking \> 400 mg clozapine/day and not on anti-seizure medication(s) with sufficient dose.
- Failed TMS screening questionnaire.
- Significant alcohol or other drug use (substance abuse within 1 month or substance dependence history within 6 months and having substance usage within 1 month) other than nicotine or marijuana dependence
- Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, CNS infection or tumor, other significant brain neurological conditions.
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any...
- History of head injury with loss of consciousness over 10 minutes; history of brain surgery
- Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
- Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive pregnancy test) or has had unprotected sexual intercourse without birth control in...
- Moderate-High Risk of suicide according to the Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e. answers YES to Question 3 and NO to Question 6 (Moderate risk); or answers YES to Questions...
- In the medical opinion of the investigator, people with the following circumstances or conditions which can increase the risk of seizures may be excluded: sleep deprivation; major depressive disorder comorbid with...
- History (or family history) of deep vein thrombosis.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.