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Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 3)

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 60 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 deep repetitive transcranial magnetic stimulation (rTMS) with an H4 coil, along with thinking-skills training. rTMS uses magnetic pulses to stimulate the brain. The study is for adults with schizophrenia-related disorders and aims to improve nerve connections in the front of the brain.

The aim of the study is to assess the treatment effects of deep active repetitive transcranial magnetic stimulation (rTMS) with H4 coil combined with cognitive training for improving frontal white matter microstructural integrity in patients with schizophrenia spectrum disorder (SSD).

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 to 60 years old.
  • You can give written consent to join the study.
  • You have a schizophrenia-related disorder and score above 10 on the Evaluation to Sign Consent (ESC), a test of your ability to consent.

Who can't join

  • You cannot sign consent, or you are a student or employee currently working with the study lab.
  • You have ever had a seizure or brain surgery, or a head injury that left you unconscious for more than 10 minutes.
  • You have a serious, unstable illness that may affect the brain, such as a recent stroke, major head injury, brain infection, or brain tumor. Most stable medical conditions do not rule you out.
  • You take more than 400 mg of clozapine a day without a high enough dose of anti-seizure medicine, or you do not pass the TMS safety screening.
  • You have had alcohol or drug abuse in the past month, or dependence in the past 6 months with use in the past month. Nicotine or marijuana dependence is not included in this rule. You also cannot join if you cannot avoid alcohol and marijuana for at least 24 hours before experiments.
  • You or your family have a history of blood clots, or you have a condition that raises your risk of blood clots.
  • You are pregnant, based on your report or a positive urine test, or you could become pregnant, use no birth control, and have missed a period.
  • You cannot have an MRI scan because of metal devices or objects in your body, or because you fear being in the scanner's tight space.

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

Official eligibility criteria

Inclusion Criteria: 1. Male and female ages between ages 18-60 years 2. Ability to give written informed consent (age 18 or above) 3. Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10. Exclusion Criteria: 1. Inability to sign informed consent. 2. Any history of seizures. 3. Any acute and unstable major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, recent stroke, seizure, history of significant head trauma, CNS infection or tumor, other significant brain neurological conditions (As this is a study of medical comorbidity, most medical conditions, once stable, are not exclusion criteria). 4. Taking \> 400 mg clozapine/day and not on anti-seizure medication(s) with sufficient dose. 5. Failed TMS screening questionnaire. 6. 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. 7. A history of thrombosis, family history of thrombosis, or medical conditions that may lead to a hypercoagulable state (increased chance to develop blood clots) 8. Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive urine pregnancy test). 9. History of head injury with loss of consciousness over 10 minutes; history of brain surgery 10. Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments. 11. Students and employees currently involved with our lab (lab employees and personnel will be excluded from the study to avoid possible coercion or possible appearance of coercion, or chance of breach of privacy and confidentiality). 12. For MRI, unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips, or other implanted metal parts) or claustrophobic to the scanner.

Study sites (1)

TX