SchizophreniaNCT00042159
Transcranial Magnetic Stimulation (TMS) Treatment for Patients With Persistent Auditory Hallucinations
A study testing repetitive transcranial magnetic stimulation in people with Schizophrenia and Hallucinations, run by Yale University at 1 site in United States.
Trial summary
This study will evaluate the long-term effects of repetitive transcranial magnetic stimulation (rTMS) in patients with auditory hallucinations. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Hallucinations
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Jun 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have persistent auditory hallucinations
Who cannot join
- 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
- Estimated IQ less than 80
- Have a sibling or parent with epilepsy
- Disorganized thought process or intellectual impairment that inhibits the ability to give an informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Psychiatric Hospital
New Haven, Connecticut, 06519
About this study
Official title: TMS Intervention Development for Auditory Hallucinations
This study will evaluate the long-term effects of repetitive transcranial magnetic stimulation (rTMS) in patients with auditory hallucinations.
Read the 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 ¼ hours and does not require any injections). After these evaluations are completed, patients will be randomly assigned (e.g., 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 (s)he 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 Wernicke's 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 (s)he received real or placebo TMS. If the patient received real TMS and experienced significant improvement in "voices", (s)he can choose to receive more stimulation to that part of the brain that produced greater improvement. If the patient has received only placebo stimulation, (s)he 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 and/or 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.
- Conditions
- Schizophrenia, Hallucinations
- Being tested
- repetitive transcranial magnetic stimulation
- Keywords
- Auditory hallucinations (voices)
- Medical subject headings
- Schizophrenia, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
1 Hertz stimulation for 16 minutes per day at 90% motor threshold, 5 sessions each to the two primary cortical targets
What is being measured
The primary outcome is the main question the study is designed to answer.
Hallucination Change Score
Measured: 2 weeks
Secondary outcomes (3)
Total AHRS score
Measured: 2 weeks
CGI
Measured: 2 weeks
Frequency subscale of AHRS
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2002 (estimated)
- Study startJul 2002
- Primary completionJul 2003
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ralph Edward Hoffman, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042159
- Sponsor's protocol ID
- R21MH063326
- Other IDs
- R21MH063326, DSIR AT-SO
- Status last verified
- Aug 2013
- First submitted
- 24 Jul 2002
- Last updated
- 6 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoffman RE, Boutros NN, Hu S, Berman RM, Krystal JH, Charney DS. Transcranial magnetic stimulation and auditory hallucinations in schizophrenia. Lancet. 2000 Mar 25;355(9209):1073-5. doi: 10.1016/S0140-6736(00)02043-2.
PubMed 10744097Hoffman RE, Hawkins KA, Gueorguieva R, Boutros NN, Rachid F, Carroll K, Krystal JH. Transcranial magnetic stimulation of left temporoparietal cortex and medication-resistant auditory hallucinations. Arch Gen Psychiatry. 2003 Jan;60(1):49-56. doi: 10.1001/archpsyc.60.1.49.
PubMed 12511172Hoffman RE, Gueorguieva R, Hawkins KA, Varanko M, Boutros NN, Wu YT, Carroll K, Krystal JH. Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. Biol Psychiatry. 2005 Jul 15;58(2):97-104. doi: 10.1016/j.biopsych.2005.03.041.
PubMed 15936729
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMS Intervention Development for Auditory Hallucinations
- ClinicalTrials.gov ID
- NCT00042159
- Acronym / sponsor ID
- R21MH063326
- Conditions
- Schizophrenia, Hallucinations
- Keywords
- Auditory hallucinations (voices)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2002
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 26 Jul 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ¼ hours and does not require any injections). After these evaluations are completed, patients will be randomly assigned (e.g., 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 (s)he 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 Wernicke's 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 (s)he received real or placebo TMS. If the patient received real TMS and experienced significant improvement in "voices", (s)he can choose to receive more stimulation to that part of the brain that produced greater improvement. If the patient has received only placebo stimulation, (s)he 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 and/or 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Have persistent auditory hallucinations
Key exclusion criteria (7 listed)
- 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
- Estimated IQ less than 80
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulation1 Hertz stimulation for 16 minutes per day at 90% motor threshold, 5 sessions each to the two primary cortical targets | Device | – |
Primary outcome
Hallucination Change Score
Time frame: 2 weeks
3 secondary outcomes
Total AHRS score
Time frame: 2 weeks
CGI
Time frame: 2 weeks
Frequency subscale of AHRS
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
- Background: PubMed 10744097Hoffman RE, Boutros NN, Hu S, Berman RM, Krystal JH, Charney DS. Transcranial magnetic stimulation and auditory hallucinations in schizophrenia. Lancet. 2000 Mar 25;355(9209):1073-5. doi: 10.1016/S0140-6736(00)02043-2.
- Background: PubMed 12511172Hoffman RE, Hawkins KA, Gueorguieva R, Boutros NN, Rachid F, Carroll K, Krystal JH. Transcranial magnetic stimulation of left temporoparietal cortex and medication-resistant auditory hallucinations. Arch Gen Psychiatry. 2003 Jan;60(1):49-56. doi: 10.1001/archpsyc.60.1.49.
- Results publication: PubMed 15936729Hoffman RE, Gueorguieva R, Hawkins KA, Varanko M, Boutros NN, Wu YT, Carroll K, Krystal JH. Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. Biol Psychiatry. 2005 Jul 15;58(2):97-104. doi: 10.1016/j.biopsych.2005.03.041.
- Click here for information about a new study at Yale assessing usefulness of rTMS in reducing voices.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation in people with Schizophrenia and Hallucinations, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hallucination Change Score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00042159, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2013.