Using targeted brain stimulation to treat auditory hallucinations in schizophrenia
Alternative Stimulation Mode and Location for Auditory Hallucination Neuromodulation Treatment
This study is testing a new brain stimulation treatment to see if it can help people with schizophrenia who hear voices feel better and improve their memory and attention.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT02916810 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of functionally navigated repetitive transcranial magnetic stimulation (TMS) on patients with schizophrenia experiencing auditory hallucinations. By using fMRI to identify specific brain areas related to these symptoms, the researchers will apply TMS to modulate abnormal electrical activities in the prefrontal cortex and associated regions. The goal is to improve symptom management and cognitive functions such as working memory and attention in participants who have not responded adequately to standard antipsychotic treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-50 diagnosed with schizophrenia-spectrum disorders who experience persistent auditory hallucinations despite treatment with multiple antipsychotic medications.
Not a fit: Patients who do not experience auditory hallucinations or those who have not been diagnosed with schizophrenia-spectrum disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce auditory hallucinations and enhance cognitive performance in patients with schizophrenia.
How similar studies have performed: Preliminary studies have shown some success in using TMS for treating auditory hallucinations, but larger trials have been limited, making this approach both promising and novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Xiaoming Du, PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Xiaoming Du, PhD
- Email: Xiaoming.Du@uth.tmc.edu
- Phone: (713) 486-2700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.