Treatment of Negative Symptoms of Schizophrenia With Transcranial Magnetic Stimulation (TMS)
Schizophrenia, Schizoaffective Disorder
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation, Schizophrenia, Schizoaffective Disorder, Treatment, Negative Symptoms, Social Dysfunction, TMS, rTMS
Eligibility Criteria
Inclusion Criteria:
- Male or female inpatients or outpatients, 18 to 55 years of age.
- Primary diagnosis by DSM-IV criteria for Schizophrenia or Schizoaffective Disorder.
- Capacity and willingness to give informed consent.
- Engaged in ongoing treatment with a psychiatrist.
- PANSS negative symptoms subscale score of ≥ 15.
- English speaking.
- Patients must have stable symptoms as defined by not requiring a change in antipsychotic medication for at least 4 weeks or at least 2 weeks for other psychotropic agents (e.g. antidepressants) prior to entering the study. Patients will not be included in the study if the research team thinks that modifications could be made to maximize their medication regimen at initial evaluation.
- Able to adhere to the treatment schedule.
- Able to commute to NYC for daily treatments (Monday - Friday) for at least 4 weeks.
Exclusion Criteria:
- Individuals diagnosed by the investigator with the following conditions (current unless otherwise stated): Current affective disorder including Major Depressive Disorder, Bipolar Affective Disorder; substance abuse or dependence within the past year (except nicotine and caffeine).
- An Axis II Personality Disorder, which in the judgment of the investigator may hinder the patient in completing the procedures required by the study protocol.
Other exclusion criteria include those common to every TMS protocol:
- Individuals with a clinically defined neurological disorder or insult including, but not limited to: Any condition likely to be associated with increased intracranial pressure; Space occupying brain lesion; Any history of seizure EXCEPT those therapeutically induced by ECT; History of cerebrovascular accident; Transient ischemic attack within two years; Cerebral aneurysm; Dementia; Parkinson's disease; Huntington's chorea; or Multiple sclerosis.
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), history of epilepsy or seizure in first-degree relatives, having metal inside the head, or history of significant head trauma with loss of consciousness for 5 minutes.
- Prior adverse reaction to TMS.
- History of treatment with rTMS therapy for any disorder.
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
- Intracranial implant (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.
- Current illicit drug use.
- Clinically significant laboratory abnormality, in the opinion of the investigator. (Note: Clinically significant laboratory abnormality refers to patient lab results that fall outside the established normal ranges, may be indicative of the presence of a medical condition, and are not thought to reflect an artifact or routine lab error (e.g. hemolysis). Results of laboratory tests are reviewed by the study physician prior to any treatment. Abnormal lab results of clinical significance that cannot be resolved (e.g. by repeating the test to rule out laboratory error or poor quality of the original sample) will lead to exclusion from the study.)
- Known or suspected pregnancy.
- Women who are breast-feeding.
- Women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse.
- Wearing medicinal skin patches during the MRI scan.
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Sham Comparator
Experimental
A
B
C
Open cross over high frequency rTMS
high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Active high frequency rTMS to the left dorsolateral prefrontal cortex
Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)