Alternative Stimulation Mode and Location for Auditory Hallucination Neuromodulation Treatment

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Sep 23, 2016

Keywords

ClinConnect Summary

This clinical trial is investigating how a treatment called repetitive Transcranial Magnetic Stimulation (TMS) can help reduce symptoms in people with schizophrenia, particularly those experiencing auditory hallucinations (hearing voices). TMS uses magnetic fields to stimulate specific areas of the brain, and in this study, researchers will target a part of the brain called the prefrontal cortex. They believe that by doing this, they can correct abnormal brain activity and improve not only the symptoms but also the participants' ability to pay attention and remember things.

To participate in this study, individuals must be at least 18 years old and diagnosed with a schizophrenia-spectrum disorder. They should have ongoing auditory hallucinations despite trying multiple medications. Participants must also be under the care of a mental health professional and agree to allow communication between the study team and their healthcare providers. This study is currently recruiting participants, and those who join can expect to receive TMS treatment and be monitored for changes in their symptoms and cognitive abilities. It's important to note that there are some exclusion criteria, such as certain medical conditions or medications, which may prevent individuals from participating.

Gender

ALL

Eligibility criteria

• Inclusion 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 service to the subject within two years of study enrollment; and (b) provide the names and verifiable contact information (name, email and mailing address, mobile and land-line phone number, as applicable) of at least two reliable persons ≥ age 22, who reside within a 30-minute drive of the subject's residence, and whom the research staff is at liberty to contact, as deemed necessary, for the duration of study participation.
• Exclusion Criteria:
• • 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 other metal object within or near the head, excluding the mouth, that cannot be safely removed.
• • 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 the last 4 weeks.
• • 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 4, 5, or 6 (High risk) or in the clinical judgement of the investigator or the study psychiatrist.
• • In the medical opinion of the investigator, subjects with the following circumstances or conditions which can increase the risk of seizures may be excluded: sleep deprivation; major depressive disorder comorbid with dementia, underweight status; concurrent use of cephalosporins and antiarrhythmics (particularly propranolol); metabolic abnormalities (hyponatremia, hypocalcemia, hypomagnesemia, hypoglycemia, hyperglycemia, renal failure/uremia, liver failure); raised blood concentrations of proconvulsant medications due to reduced clearance (e.g. secondary to initiation of antibiotics for treatment of infections); alcohol withdrawal; use of stimulants, such as cocaine or MDMA; use of immunosuppressive therapy with cyclosporine, tacrolimus and other agents that can cause the posterior reversible leukoencephalopathy syndrome; dialysis; systemic infection, and fever itself.
• • History (or family history) of deep vein thrombosis.