|
TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices") Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices") conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices") Clinical research trials and TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices") health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices"). TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices") Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices") clinical trial. Test subjects typically receive the most expert healthcare available for their TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices") condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices")  TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices")
TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices")
For Condition: Schizophrenia,Hallucinations
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to evaluate the long-term effects of repetitive transcranial magnetic stimulation (rTMS) in patients with auditory hallucinations ("voices"). A second goal is to test an alternative method for positioning rTMS.
Details: Auditory hallucinations can cause distress, functional disability, and problems in controlling behavior. In addition, auditory hallucinations are often resistant to drug treatment. Brain imaging studies suggest that voices arise from parts of the brain that are ordinarily involved in perceiving spoken speech. In rTMS, an electromagnet is placed on the scalp and causes magnetic pulses to pass through the skull and stimulate the underlying cerebral cortex (a part of the brain). Low frequency rTMS is known to reduce reactivity or excitability of the part of the brain directly stimulated without producing any actual damage to brain tissue. This study will determine if low frequency rTMS directed to brain areas responsible for speech processing can be used as an alternative treatment for auditory hallucinations and other psychotic symptoms. Prior to study entry, patients have their cognitive abilities assessed. Patients are then assigned randomly to receive either rTMS or a placebo form of stimulation over a 9-day period. Patients are carefully monitored with tests of concentration and memory throughout the trial. If a patient has been assigned to the placebo group, after the 9-day trial is completed, (s)he is offered a trial of real rTMS. If a patient finds that rTMS is helpful, but still suffers a return of symptoms, he or she may enroll in an additional trial in which stimulation is given for a longer period of time. Follow up occurs for 1 year to determine the long-term effects of rTMS. rTMS is generally not painful, but can be uncomfortable if a tingling or knocking sensation is produced. Contraction of scalp and facial muscles sometimes occurs. There is a very small risk of seizure associated with rTMS, but for the frequency of stimulation used in this study (1 stimulation per second), the risk is significant only for patients who have had a prior history of seizures. Schizophrenia patients with very frequent hallucinations are studied using an rTMS protocol where positioning of the stimulation coil is based on a brain scan generated by functional magnetic resonance imaging (fMRI). The fMRI scan is used to locate those brain area that appear to be involved in the production of these hallucinations for individual patients. We wish to test the hypothesis that using these brain imaging data to guide positioning of rTMS will enhance treatment outcome.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Have persistant auditory hallucinations Exclusion Criteria: - History of neurological disorder - Serious, unstable medical conditions (persons with hypertension or diabetes mellitus may enroll if these conditions are treated and stable) - Active drug or alcohol abuse (persons may enroll if they have a history of drug or alcohol abuse provided that they do not use these substances at least 4 weeks prior to study initiation) - History of seizures unrelated to drug withdrawal - Have a sibling or parent with epilepsy - Estimated IQ less than 80 - Disorganized thought process or intellectual impairment that inhibits the ability to give an informed consent
Total Enrollment: 70
Location and Contact Information:
Yale-New Haven Psychiatric Hospital, 20 York Street *Recruiting*
New Haven, Connecticut, 06504
United States
Recruiting Ralph Hoffman 203-688-9734
Additional Information:
Study ID Numbers: 63326-01;
Study Start Date: April 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042159
Other Hallucinations Studies:
1. Treatment of Childhood Onset Psychiatric Disorders with Intravenous Immunoglobulin (IVIg)
2. Imaging of Brain Receptors in Healthy Volunteers and in Patients with Schizophrenia
3. Improving Health Services for Veterans with Schizophrenia
4. CATIE- Schizophrenia Trial
5. CAFE Comparison of Atypicals in First Episode
Related Studies:
Other Hallucinations Clinical Trials
Other Connecticut Clinical Trials
Other New Haven Clinical Trials
TMS Treatment for Patients with Persistent Auditory Hallucinations ("Voices")
|
|
|
|
|
|
|
|
