Treating Refractory Schizophrenia With rTMS

Stopped early · Not applicable · Has a placebo group

Conditions studied: Schizophrenia

In brief

Symptomatic treatment of the negative symptoms in schizophrenia (such as social withdrawal, affective flattening, poor motivation, and apathy) with medications and psychotherapy are almost non-existent, whereas treatment of the positive symptoms (hallucinations and delusions) has been more effective with psychotropic medications. The proposed research on human subjects using a non-invasive technology (such as repetitive transcranial magnetic stimulation \[rTMS\]) will provide efficacy data for treating negative symptoms. The hypotheses are that 1) Cerebellar stimulation will cause activation of thalamic and frontal cortical networks associated with attentional processes as a component of the "distracted" affect of schizophrenia; 2) Cerebellar stimulation will cause activation of the reticular activating system (RAS), and this will allow the "mutism", which is a negative symptom, to be partially improved.

Key facts

Study ID

NCT02242578

Run by

Seton Healthcare Family

People needed

2

Starts

2011-01-24

Expected to finish

2018-06-11

Last updated by the study team

2021-04-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients enrolling to the study:
• must be stable on their medications at the start of their enrollment in the study and throughout the duration of the study;
• must have no history of substance use of substance-dependence issues over at least the past six months;
• must be able to and have the capacity to provide consent;
• and if older patient, he/she must be able to participate without a safeguard to be present.

You may not qualify if…

• Patients excluded from the study are:
• Patients with typical clinical considerations that exclude them from treatment with TMS (i.e., patients who have had head injuries, patients with metal implants, patients with a history of seizures, patients with elevated risk of seizures, patients who are taking medications that may interfere with TMS or potentiate the related side effects, etc.).
• Patients who have had changes in their medications (i.e., patients must be stable on their medications throughout their participation in the study).
• Patients with history of substance abuse or substance-dependence anytime over the past six months.
• Patients who are unable (i.e., do not have the capacity) to consent.

Where it is running

• Seton Brain and Spine Institute "Brain Stimulation Laboratory" — Austin, Texas, United States

Full record on ClinicalTrials.gov

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