Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042159
Status:
COMPLETED
Last Update Posted:
2013-08-06
First Post:
2002-07-24
Brief Title:
Transcranial Magnetic Stimulation TMS Treatment for Patients With Persistent Auditory Hallucinations
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
TMS Intervention Development for Auditory Hallucinations
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the long-term effects of repetitive transcranial magnetic stimulation rTMS in patients with auditory hallucinations
Detailed Description:
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 TMS an electromagnet placed on the scalp produces magnetic pulses that pass through the skull and stimulate the underlying cerebral cortex a part of the brain Low frequency once per second TMS is known to reduce reactivity or excitability of the part of the brain directly stimulated without damaging 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 related psychotic symptoms
Before starting rTMS patients will undergo 1 a medical and psychiatric evaluation 2 neuropsychological tests to assess concentration and memory abilities and 3 an fMRI brain scan which takes about 1 ΒΌ hours and does not require any injections After these evaluations are completed patients will be randomly assigned eg by the flip of a coin to receive either low frequency rTMS or placebo stimulation for 16 minutes per day over a 10-day period During this time the patient will not know whether she is receiving the real or the placebo stimulation For 5 days stimulation will be administered to an area of the left temporal lobe of the brain that is involved in perceiving speech This area is called Wernickes area For another 5-day period a similar area on the right side of the brain will be stimulated After the 10-day trial is completed the patient will be told if she received real or placebo TMS If the patient received real TMS and experienced significant improvement in voices she can choose to receive more stimulation to that part of the brain that produced greater improvement If the patient has received only placebo stimulation she will then be offered a trial of real rTMS
TMS is generally not painful but can be uncomfortable due to a tingling or knocking sensation andor contraction of scalp and facial muscles There is a small risk of seizure associated with TMS but for the frequency of stimulation used in this study 1 stimulation per second this risk is significant only for patients who have a prior history of seizures epilepsy or other neurological problem We have given TMS to more than 90 persons with schizophrenia and auditory hallucinations and have not had a case of seizure We are also concerned that TMS may cause memory or concentration problems Therefore we carefully monitor patients for early signs of such difficulties using daily questionnaire assessments and weekly neuropsychological tests If we suspect that a patient is experiencing problems with memory or concentration the trial is stopped A small percentage of patients in our previous studies less than 5 reported problems with memory that ended soon after the trial was stopped
Before starting rTMS patients will undergo 1 a medical and psychiatric evaluation 2 neuropsychological tests to assess concentration and memory abilities and 3 an fMRI brain scan which takes about 1 ΒΌ hours and does not require any injections After these evaluations are completed patients will be randomly assigned eg by the flip of a coin to receive either low frequency rTMS or placebo stimulation for 16 minutes per day over a 10-day period During this time the patient will not know whether she is receiving the real or the placebo stimulation For 5 days stimulation will be administered to an area of the left temporal lobe of the brain that is involved in perceiving speech This area is called Wernickes area For another 5-day period a similar area on the right side of the brain will be stimulated After the 10-day trial is completed the patient will be told if she received real or placebo TMS If the patient received real TMS and experienced significant improvement in voices she can choose to receive more stimulation to that part of the brain that produced greater improvement If the patient has received only placebo stimulation she will then be offered a trial of real rTMS
TMS is generally not painful but can be uncomfortable due to a tingling or knocking sensation andor contraction of scalp and facial muscles There is a small risk of seizure associated with TMS but for the frequency of stimulation used in this study 1 stimulation per second this risk is significant only for patients who have a prior history of seizures epilepsy or other neurological problem We have given TMS to more than 90 persons with schizophrenia and auditory hallucinations and have not had a case of seizure We are also concerned that TMS may cause memory or concentration problems Therefore we carefully monitor patients for early signs of such difficulties using daily questionnaire assessments and weekly neuropsychological tests If we suspect that a patient is experiencing problems with memory or concentration the trial is stopped A small percentage of patients in our previous studies less than 5 reported problems with memory that ended soon after the trial was stopped
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR AT-SO | US NIH GrantContract | None | httpsreporternihgovquickSearchR21MH063326 |
| R21MH063326 | NIH | None | None |