Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00308997 |
This study will determine the efficacy of MRI-guided transcranial magnetic stimulation (TMS)in reducing "voices" and other symptoms experienced by people with schizophrenia and schizoaffective disorder. In addition, the study will determine duration of improvement obtained during the course of trial participation via on-going monthly contact with study participants for up to 1 year after the trial.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia Hallucinations |
Device: 1-hertz Repetitive Transcranial Magnetic Stimulation Device: Active 1-Hertz Repetitive transcranial magnetic stimulation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Transcranial Magnetic Stimulation Guided by Neuroimaging for Patients With Persistent "Voices" |
Estimated Enrollment: | 90 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
|
Device: Active 1-Hertz Repetitive transcranial magnetic stimulation
Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
2: Sham Comparator
sham rTMS to Wernicke's area and a right homologous area
|
Device: 1-hertz Repetitive Transcranial Magnetic Stimulation
Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
Schizophrenia is a severely disabling brain disorder that affects about 1% of the United States population. Approximately 50 to 80% of people with schizophrenia experience "voices," also known as auditory hallucinations. These hallucinations consist of spoken speech, which sometimes replicates the speaking voice of a familiar person, and sometimes reflects a speaking voice that is not known but becomes highly recognizable. The phrases and sentences expressed by "voices" are often highly disruptive, and may comment, cajole, criticize, and, in some cases, command the patient. They are often but not invariably distressing, and can disrupt one's ability to interact with others, work, study, and sleep. In about 25% of cases, medication treatment is either completely ineffective or only partially effective in relieving "voices." Effective treatment alternatives are needed to improve this troubling and often disabling symptom.
Recent studies have suggested that auditory hallucinations arise from parts of the brain that are ordinarily involved in perceiving actual spoken speech. Low frequency repetitive transcranial magnetic stimulation (rTMS), a technique that uses an electromagnet to induce reductions in cortical brain activity, may therefore be effective in quieting auditory hallucinations. The potential usefulness of this approach has been demonstrated by previous studies conducted at our medical center. This new study uses magnetic resonance imaging (MRI) to locate two areas of the brain involved in speech perception. These areas are in Wernicke's area in the left superior temporal gyrus, and in the right hemisphere in an analogous site in the superior temporal gyrus. Repetitive TMS is specifically positioned to reduce cortical excitability or reactivity at these two brain regions.
Participants in this double blind study will be randomly assigned to receive either real rTMS, or placebo stimulation, which feels similar to real rTMS but does not produce direct brain effects. Depending on group assignment, participation may last 4 to 8 weeks. Over the first 2 weeks, all participants will undergo two sequences of rTMS, each consisting of five 16-minute sessions. One sequence is directed to left Wernicke's area and the other sequence is directed to the right-sided equivalent area. During the third week, participants will receive five additional sessions to the left or right site that appeared to produce greater clinical improvement. All participants will then be informed as to whether they received real or placebo stimulation. Participants who received real stimulation will be offered 5 additional stimulation sessions at the brain site that achieved the best response. Participants who received placebo stimulation will be offered real stimulation for up to twenty sessions over 4 weeks using the same schedule described above. Assessments of severity of hallucinations and other clinical symptoms will be conducted after every fifth rTMS session by a clinician who does not know whether the participant is receiving real or placebo stimulation.
Neuropsychological testing will also be done before, during, and after the trial. Our previous trial demonstrated some improvement in verbal processing with no significant impairments in terms of memory, language or cognitive function. However, insofar as this trial involves a greater total "dose" of rTMS, careful monitoring of these functions is conducted throughout the trial.
In addition, the study will determine the degree to which improvement obtained during the course of trial is sustained over the ensuing months. This is accomplished via on-going monthly contact with study participants for up to 1 year after the last rTMS stimulation session.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ralph E. Hoffman, MD | 203-688-9734 | ralph.hoffman@yale.edu |
United States, Connecticut | |
Yale Psychiatric Research | Recruiting |
New Haven, Connecticut, United States, 06519 | |
Contact: Joan Nye, BA 203-737-2762 joan.nye@yale.edu | |
Contact: Ralph E. Hoffman, MD 203-688-9734 ralph.hoffman@yale.edu |
Principal Investigator: | Ralph E. Hoffman, MD | Yale University School of Medicine, Department of Psychiatry |
Responsible Party: | Yale University School of Medicine ( Ralph Hoffman ) |
Study ID Numbers: | R01 MH73673, DATR A5-ETPD |
Study First Received: | March 28, 2006 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00308997 |
Health Authority: | United States: Federal Government |
Auditory Hallucinations Schizophrenia Schizoaffective Disorder |
Repetitive Transcranial Magnetic Stimulation Wernicke's Area Superior Temporal Gyrus |
Schizophrenia Signs and Symptoms Mental Disorders Hallucinations Neurologic Manifestations |
Psychotic Disorders Neurobehavioral Manifestations Schizophrenia and Disorders with Psychotic Features Perceptual Disorders |
Nervous System Diseases |