SchizophreniaPhase 2NCT00004980
Repetitive Transcranial Magnetic Stimulation for "Voices"
A Phase 2 study testing repetitive transcranial magnetic stimulation (rTMS) in people with Schizophrenia, run by Yale University at 1 site in United States.
Trial summary
OBJECTIVES: I. Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Jun 2005
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV version of SCID
- Auditory hallucinations of spoken speech occurring at least 5 times per day where subject able to discern verbal content
- Right-handed
- At least 4 weeks on stable antipsychotic medication
Who cannot join
- history of seizure (unless due to drug withdrawal or medication that is no longer prescribed)
- history of epilepsy in first degree relatives
- estimated IQ less than 80
- unable to provide informed consent
- significant unstable medical condition
- current treatment with clozapine or bupropion
Show all 11Show fewer
- cochlear implants or other metal in the head (surgical, etc.)
- history of cardiac arrhythmia
- cardiac pacemaker
- active drug or alcohol abuse within prior 6 weeks
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520-8099
About this study
Official title: Repetitive Transcranial Magnetic Stimulation of Speech Processing Brain Areas in Schizophrenic Patients Who Hear "Voices"
OBJECTIVES:
- Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to one of two treatment arms.
Group I: Patients receive 9 sessions of active transcranial magnetic stimulation (rTMS) which consists of 8 minutes of rTMS during session 1, 12 minutes duration during session 2, and 16 minutes duration during sessions 3-9. The total duration of stimulation is 132 minutes. Each session was given on a separate day and in general each session occurred on consecutive days with the exception of weekends.
Group II: Patients receive 9 sessions of sham stimulation, which consists of 8 minutes of sham stimulation during session 1, 12 minutes duration sham stimulation during session 2, and 16 minutes duration sham stimulation during sessions 3-9. The total duration of sham stimulation is 132 minutes. Each session was given conducted on a separate day and in general each session occured on consecutive days with the exception of weekends.
This study provided pilot data supplying the basis for our current study - NCT00308997 -- see our website for details
- Conditions
- Schizophrenia
- Being tested
- repetitive transcranial magnetic stimulation (rTMS), sham stimulation
- Keywords
- neurologic and psychiatric disorders, rare disease, schizophrenia
- Medical subject headings
- Schizophrenia, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (rTMS)Device
Also called MATSTIM SUPER RAPID
a total of 132 minutes of stimulation at one hertz, motor threshold set at 80%, delivered to TP3 scalp site
sham stimulationDevice
Also called MAGSTIM SUPER RAPID
132 minutes of stimulation given at 80% motor threshold with coil tilted "single wing" 45 degrees away from scalp deliverd to TP3 site
| Study group | Role | What they receive |
|---|---|---|
| active rTMS | Experimental | 1-Hz rTMS delivered to left temporoparietal cortex at 90% motor threshold for 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends) Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
| sham stimulation | Placebo comparator | Sham stimulation delivered 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends) Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions
Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline
Measured: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Secondary outcomes (3)
Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions
Difference between baseline hallucination frequency and hallucintion frequency at last assessment. Assessed on the basis of a 0-9 scale, with higher scores being more severe.
Measured: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions
Scaled from 1-7 as follows: 1=dramatically improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worsened, 6=moderately worsened, 7=dramatically worsened
Measured: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Responder Status
Responder defined as a participant who attains an endpoint hallucination change score (HCS) of 5 or lower after 9 active/shame rTMS sessions.
Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline
Measured: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2000 (estimated)
- Study startDec 1999
- Primary completionJan 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 2
- 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
- Sponsor
- Investigators
- Ralph Hoffman, Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004980
- Sponsor's protocol ID
- R21MH063326
- Other IDs
- R21MH063326, YALESM-9281, 199/14809, A5-ETPD
- Status last verified
- Aug 2013
- First submitted
- 10 Mar 2000
- Last updated
- 7 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hoffman 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 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation of Speech Processing Brain Areas in Schizophrenic Patients Who Hear "Voices"
- ClinicalTrials.gov ID
- NCT00004980
- Acronym / sponsor ID
- R21MH063326
- Conditions
- Schizophrenia
- Keywords
- neurologic and psychiatric disorders, rare disease, schizophrenia
- Phase
- Phase 2
- 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
- Dec 1999
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 13 Mar 2000 (estimated)
- Results
- Posted 9 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to one of two treatment arms.
Group I: Patients receive 9 sessions of active transcranial magnetic stimulation (rTMS) which consists of 8 minutes of rTMS during session 1, 12 minutes duration during session 2, and 16 minutes duration during sessions 3-9. The total duration of stimulation is 132 minutes. Each session was given on a separate day and in general each session occurred on consecutive days with the exception of weekends.
Group II: Patients receive 9 sessions of sham stimulation, which consists of 8 minutes of sham stimulation during session 1, 12 minutes duration sham stimulation during session 2, and 16 minutes duration sham stimulation during sessions 3-9. The total duration of sham stimulation is 132 minutes. Each session was given conducted on a separate day and in general each session occured on consecutive days with the exception of weekends.
This study provided pilot data supplying the basis for our current study - NCT00308997 -- see our website for details
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active rTMS | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS)1-Hz rTMS delivered to left temporoparietal cortex at 90% motor threshold for 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends) |
| sham stimulation | Placebo comparator | Device: sham stimulationSham stimulation delivered 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV version of SCID
- Auditory hallucinations of spoken speech occurring at least 5 times per day where subject able to discern verbal content
- Right-handed
- At least 4 weeks on stable antipsychotic medication
Key exclusion criteria (11 listed)
- history of seizure (unless due to drug withdrawal or medication that is no longer prescribed)
- history of epilepsy in first degree relatives
- estimated IQ less than 80
- unable to provide informed consent
- significant unstable medical condition
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 stimulation (rTMS)Also: MATSTIM SUPER RAPIDa total of 132 minutes of stimulation at one hertz, motor threshold set at 80%, delivered to TP3 scalp site | Device | active rTMS |
| sham stimulationAlso: MAGSTIM SUPER RAPID132 minutes of stimulation given at 80% motor threshold with coil tilted "single wing" 45 degrees away from scalp deliverd to TP3 site | Device | sham stimulation |
Primary outcome
Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions
Time frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline
3 secondary outcomes
Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions
Time frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions
Time frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Responder Status
Time frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 the Yale School of Medicine Web site describing current, on-going rTMS trial for auditory hallucinationsLink 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.
Ralph Hoffman study chair
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing repetitive transcranial magnetic stimulation (rTMS) in people with Schizophrenia, 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 4 inclusion and 11 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 7 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (HCS) After 9 Active/Sham rTMS Sessions (time frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)). 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 NCT00004980, which also lists 1 linked publication.
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 7 Aug 2013.