RecruitingNot applicable

Alternative Stimulation Mode and Location for Auditory Hallucination Neuromodulation Treatment

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests repeated TMS, which uses magnetic pulses to stimulate the brain, in adults with schizophrenia-related disorders who still hear sounds or voices despite treatment. Researchers will choose a treatment spot in the front of each person's brain based on their brain connections. They will test whether this changes unusual brain activity, reduces symptoms, and improves memory and attention.

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). The investigators predict that such modulation will correct abnormal activities in patients with schizophrenia, reduce symptoms, especially auditory hallucination, and improve working memory/sustained attention performance.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–50 years old.
  • You can give written consent and score above 10 on the Evaluation to Sign Consent, a test of your ability to agree to the study.
  • You have a schizophrenia-spectrum disorder, a group of related mental health conditions.
  • You are under the care of a licensed primary care or mental health provider.
  • You still have auditory hallucinations—hearing sounds or voices that are not there—after treatment with at least two antipsychotic medicines, including one called an atypical antipsychotic.
  • You agree to give written permission for study staff to communicate with your current health care providers and those who treated you within the past two years.
  • You provide names and contact details for at least two reliable people age 22 or older who live within a 30-minute drive of you. Study staff must be allowed to contact them during the study.

Who can't join

  • You have a parent, sibling, or child with inherited epilepsy or seizures, answer yes to certain seizure-screening questions, or do not pass the TMS safety screening.
  • You take more than 400 mg of clozapine a day without a high enough dose of anti-seizure medicine. A study doctor may also exclude you for other seizure risks, such as lack of sleep, certain medicines, illness, or alcohol withdrawal.
  • You have recent alcohol or drug abuse, or recent dependence with use in the past month, except nicotine or marijuana dependence. You cannot avoid alcohol or marijuana for at least 24 hours before study tests.
  • You have a major illness that may affect brain function, such as a stroke, brain infection, or brain tumor; past brain surgery; or a head injury that made you pass out for more than 10 minutes.
  • You have a pacemaker, implanted medicine pump, a tube inside your heart, or serious unstable heart disease. You have an implant inside your skull or metal in or near your head, outside the mouth, that cannot be safely removed.
  • You are pregnant, or you have had sex without birth control in the past four weeks.
  • A suicide-risk screening or study clinician finds that you have a moderate or high risk of suicide.
  • You or someone in your family has had deep vein thrombosis, a blood clot in a deep vein.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TX