SchizophreniaNCT01595503

Transcranial Magnetic Stimulation for the Treatment of Auditory Hallucinations in Schizophrenia

A study testing rTMS with fMRI-based targeting and rTMS with landmark-based targeting in people with Schizophrenia, run by University of Michigan at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Schizophrenia
What is being tested?: rTMS with fMRI-based targeting and rTMS with landmark-based targeting
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: May 2011to Aug 2012
Phase: Interventional
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

Provide signed and dated informed consent form
Male or female, aged 18 to 60
Willing to comply with all study procedures and be available for the duration of the study
Primary diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV (29)
Currently reporting AHs, rated a minimum of 4 (moderate) on the auditory hallucination item of the Brief Psychiatric Rating Scale (BPRS; 27), and AH will be present daily
AHs must have failed to resolve after a minimum of two adequate trials (doses within standard therapeutic range for a minimum of 8 weeks each) of psychotropic medication including at least one atypical antipsychotic medication; documented trials of antipsychotic medication limited by intolerable side effects, e. g. extra-pyramidal symptoms, tardive dyskinesia, weight gain, neuroleptic-induced dysphoria, will also be considered as equivalent to adequate trials.
Weight and girth compatible with the bore of the MRI scanner; generally men over 6 feet tall < 250 lbs, men under 6 feet tall < 220 lbs, women over 5'11" tall < 220 lbs, or women under 5'10" tall < 200 lbs

Who cannot join

Substance abuse or dependence in the past 1 month
Current or past history of serious medical or neurological illness that could compromise brain function or present an increased risk of seizure, e. g. conditions that may significantly alter electrolyte balance, stroke, epilepsy, any history of seizure;
Pregnant or trying to become pregnant;
Inability to tolerate small, enclosed spaces without anxiety;
Metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles, neurostimulators, foil-backed transdermal patches;
Facial tattoos with metallic ink

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Inability to follow study protocol
Change in antipsychotic therapy in previous 2 weeks
Currently under an alternative treatment order
Unstable symptoms which could, in the judgment of the study team, exhibit symptomatic worsening over the course of the protocol
Current treatment with another investigational drug or other intervention
Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study;
No quantifiable motor threshold such that TMS dosage cannot be accurately determined

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Department of Psychiatry Depression Center
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Functional Targeting of Transcranial Magnetic Stimulation for the Treatment of Refractory Auditory Hallucinations in Schizophrenia

Repetitive transcranial magnetic stimulation (rTMS) is a new noninvasive therapy that uses magnetic energy applied to the scalp to modulate activity in the underlying regions of the brain. In this study we will examine the efficacy of treating auditory hallucinations in schizophrenia with rTMS, comparing two methods to target stimulation to a language processing region of the brain. One method targets the stimulation site using scalp landmarks, while the other uses functional magnetic resonance imaging (fMRI) combined with a language task.

Conditions: Schizophrenia
Being tested: rTMS with fMRI-based targeting, rTMS with landmark-based targeting
Keywords: Schizophrenia, auditory hallucination
Medical subject headings: Schizophrenia, Hallucinations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rTMS with fMRI-based targetingProcedure or surgery
Inhibitory (low frequency) 1-Hz rTMS will be applied to the secondary auditory cortex during 10 daily 20-minute treatment sessions. An fMRI scan combined with a language task will be used to localize the secondary auditory cortex, followed by neuronavigation to identify the scalp location overlying the targeted cortex.
rTMS with landmark-based targetingProcedure or surgery
Inhibitory (low frequency) 1-Hz rTMS will be applied over the left temporoparietal cortex (TPC) during 10 daily 20-minute treatment sessions, with the stimulating coil located midway between the left temporal (T3) and parietal (P3) scalp landmarks, using the International 10-20 system for EEG.

Study groups in NCT01595503
Study group	Role	What they receive
fMRI-based targeting	Experimental	Not described Receives: Procedure: rTMS with fMRI-based targeting
landmark-based targeting	Active comparator	Not described Receives: Procedure: rTMS with landmark-based targeting

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Severity of Auditory Hallucinations
Hallucination Change Scale (Hoffman RE, Gueorguieva R, Hawkins KA, Varanko M, Boutros NN, Wu YT, et al. (2005): Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. Biol Psychiatry. 58:97-104.) Baseline score, by definition: 10 Range: 0 (no hallucinations) to 20 (hallucinations twice as bad as baseline) Thus, a score of less than 10 means that hallucinations were reduced, whereas a score of greater than 10 means that hallucinations were increased.
Measured: Two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Aug 2012

First posted10 May 2012 (estimated)
Study startMay 2011
Primary completionAug 2012
Study completionAug 2012

Why it stopped: Insufficient recruitment

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.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by University of MichiganThe 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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01595503
Sponsor's protocol ID: HUM00046254
Status last verified: Nov 2021
First submitted: 8 May 2012
Last updated: 8 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Functional Targeting of Transcranial Magnetic Stimulation for the Treatment of Refractory Auditory Hallucinations in Schizophrenia
ClinicalTrials.gov ID: NCT01595503
Acronym / sponsor ID: HUM00046254
Conditions: Schizophrenia
Keywords: Schizophrenia, auditory hallucination
Study type: Interventional
Recruitment status: TerminatedReason stopped: Insufficient recruitment
Enrolment: 5 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: May 2011
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 10 May 2012 (estimated)
Results: Posted 8 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
fMRI-based targeting	Experimental	Procedure: rTMS with fMRI-based targeting
landmark-based targeting	Active comparator	Procedure: rTMS with landmark-based targeting

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Provide signed and dated informed consent form
Male or female, aged 18 to 60
Willing to comply with all study procedures and be available for the duration of the study
Primary diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV (29)
Currently reporting AHs, rated a minimum of 4 (moderate) on the auditory hallucination item of the Brief Psychiatric Rating Scale (BPRS; 27), and AH will be present daily

Key exclusion criteria (13 listed)

Substance abuse or dependence in the past 1 month
Current or past history of serious medical or neurological illness that could compromise brain function or present an increased risk of seizure, e. g. conditions that may significantly alter electrolyte balance, stroke, epilepsy, any history of seizure;
Pregnant or trying to become pregnant;
Inability to tolerate small, enclosed spaces without anxiety;
Metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles, neurostimulators, foil-backed transdermal patches;

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
rTMS with fMRI-based targetingInhibitory (low frequency) 1-Hz rTMS will be applied to the secondary auditory cortex during 10 daily 20-minute treatment sessions. An fMRI scan combined with a language task will be used to localize the secondary auditory cortex, followed by neuronavigation to identify the scalp location overlying the targeted cortex.	Procedure or surgery	fMRI-based targeting
rTMS with landmark-based targetingInhibitory (low frequency) 1-Hz rTMS will be applied over the left temporoparietal cortex (TPC) during 10 daily 20-minute treatment sessions, with the stimulating coil located midway between the left temporal (T3) and parietal (P3) scalp landmarks, using the International 10-20 system for EEG.	Procedure or surgery	landmark-based targeting

Primary outcome

Change in Severity of Auditory Hallucinations
Time frame: Two weeks
Hallucination Change Scale (Hoffman RE, Gueorguieva R, Hawkins KA, Varanko M, Boutros NN, Wu YT, et al. (2005): Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. Biol Psychiatry. 58:97-104.) Baseline score, by definition: 10 Range: 0 (no hallucinations) to 20 (hallucinations twice as bad as baseline) Thus, a score of less than 10 means that hallucinations were reduced, whereas a score of greater than 10 means that hallucinations were increased.

Results and safety

Results posted to the registry on 8 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rTMS With Either fMRI-based Targeting or Landmark Based Targeting.	5	5

Primary outcome: Change in Severity of Auditory Hallucinations

Time frame: Two weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	rTMS n = 5
Value	5.9 (1.7)

Population analysed: The two original groups: with fMRI targeted and landmark based were planned to be analyzed separately, the data available at the time of results reporting, is no longer separable. Thus all treated participants are included in a single arm. While this does not allow comparison between the two approaches to rTMS usage, it still allows one to see the impact of using rTMS with one method or the other, albeit still in a tiny sample size.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rTMS	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
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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.

Stephan F Taylor, M.D. principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing rTMS with fMRI-based targeting and rTMS with landmark-based targeting in people with Schizophrenia, run by University of Michigan 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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 8 Dec 2021. 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?

Yes. Results are posted in the registry (first posted 8 Dec 2021). 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?

Change in Severity of Auditory Hallucinations (time frame: Two 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 NCT01595503.

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 8 Dec 2021.