Schizophrenia/Schizoaffective: Transcranial Magnetic Stimulation Guided by Neuroimaging for Patients with Persistent Voices

Contact name: Joan L. Nye

Phone: (203)-737-2762

Fax: (203)-785-7855

Email: joan.nye@yale.edu

Disorder: Schizophrenia, schizoaffective disorder

Geographic location: The study is conducted in New Haven CT but patient volunteers nationwide who are willing to travel to New Haven have been included in the study

Other keywords: auditory hallucinations, voices, transcranial magnetic stimulation, schizophrenia

Participant compensation: $400

Time commitment required: 5-7 weeks

Drug trial: No

Recruitment end date (approximate): July 2006

Study criteria (i.e., age or gender requirements):
Patient volunteers need to be 18-55 years old, have a diagnosis of schizophrenia, schizoaffective disorder, or affective disorder (depression or bipolar disorder), and experience “voices” at least 3-4 times per day. The patient needs to undergo an MRI scan. Patients will need to stay on a steady dose of psychiatric medication for the duration of the trial, but we do not require patients to be on psychiatric medication in order to enroll in the trial.

Exclusion criteria:
Patients cannot abuse drugs or alcohol for at least 30 days prior to study enrollment and during the study itself. Individuals with a history of seizures or family history of epilepsy, or serious medical conditions may not participate in the study. Also people who have metal in their bodies (due, for example, to orthopedic surgery) may not be able to undergo MRI scanning.

Brief description of study:
Transcranial magnetic stimulation (TMS) utilizes an electromagnet placed on the scalp that generates magnetic field pulses roughly the strength of an MRI scan. The magnetic pulses pass readily through the skull and stimulate the underlying cerebral cortex. Using information from a special MRI scan, we select two regions of the brain that appear to be involved in producing voices. Roughly ˝ the persons in the study start out receiving the real stimulation and ˝ of patients receive a placebo form of stimulation that feels similar to real stimulation but does not produce the direct brain effects; the patient and everyone outside of the TMS team will not know what type of stimulation is being administered during this initial time period. Each of two brain areas located using the FMRI scanning data is tested with five daily 16-minute sessions of TMS to determine which area, upon stimulation, produces the greatest symptom improvement. After 2 weeks, we then tell the patient whether (s)he received the real stimulation or the placebo stimulation. If the patient had received real stimulation, (s)he will be offered a trial of an additional two weeks of real stimulation at the stimulation site producing the greatest improvement during the first two weeks of the trial. If the patient had received placebo stimulation, (s)he will be offered the real stimulation for up to 20 stimulation sessions over four weeks. Thus everyone enrolled in the study has the opportunity of finding out whether TMS is helpful in improving voices. Patient volunteers have the option of staying at no cost on a research inpatient unit at the Connecticut Mental Health Center. Reasonable transportation costs to and from New Haven are also covered.

Additional information: