SchizophreniaNCT00875498
Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia
A study testing active iTBS in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
Trial summary
The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- active iTBS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Jul 2015
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Schizophrenia according to DSM-IV
- Negative symptoms for at least 6 weeks
- Medication resistance according to Kane et al., 1988
- Age between 18 and 50 years old
- Informed consent
Who cannot join
- Contraindication to TMS
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia.
Read the detailed description
This study will evaluate whether the intermittent Theta Burst Stimulation (iTBS), a new high frequency TMS protocol is efficient in the treatment of the Negative Symptoms of schizophrenia.
Neuroimaging studies demonstrate that hypoactivity in the left dorsolateral prefrontal cortex (LDLPFC) was associated with negative symptoms.
The investigators hypothesize that iTBS applied to LDLPFC will improve negative symptoms and will improve activity of the LDLPFC measured with Magnetic Resonance Spectroscopy (MRS).
- Conditions
- Schizophrenia
- Being tested
- active iTBS, sham iTBS
- Keywords
- iTBS, Negative Symptoms
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active iTBSProcedure or surgery
Also called TMS, rTMS, TBS, iTBS
Intermittent Theta Burst Stimulation (iTBS) over Left dorsolateral prefrontal cortex.
80% MT, 20 sessions of 6 minutes, 2 per day
sham iTBSProcedure or surgery
Also called placebo TMS, placebo rTMS
iTBS placebo (placebo coil)
| Study group | Role | What they receive |
|---|---|---|
| active iTBS | Active comparator | iTBS active intensity = 80%MT during 6 minutes. 20 sessions, 2 per day Receives: Procedure: active iTBS |
| sham iTBS | Placebo comparator | iTBS placebo (placebo coil)with same parameters than active Receives: Procedure: sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for the Assessment of Negative Symptoms (SANS)
Measured: before, after 2 weeks of treatment, and 3 times follow-up (1, 3 and 6 months)
Secondary outcomes (1)
Neurochemical impact of treatment measured by 1H-MRS, DTI and resting MRI
Measured: 3 times, before treatment, immediatly after treatment and a last evaluation 3 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startNov 2008
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe 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, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. E. Poulet, Hôpital le Vinatier
- Investigators
- Emmanuel Poulet, MD, PhD, Principal investigator, Hopital Le VinatierJEROME BRUNELIN, PhD, Study director, Hopital le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875498
- Sponsor's protocol ID
- 2008-A00558-47
- Status last verified
- Jan 2016
- First submitted
- 2 Apr 2009
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia
- ClinicalTrials.gov ID
- NCT00875498
- Acronym / sponsor ID
- 2008-A00558-47
- Conditions
- Schizophrenia
- Keywords
- iTBS, Negative Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Apr 2009 (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.
The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia.
Detailed description
This study will evaluate whether the intermittent Theta Burst Stimulation (iTBS), a new high frequency TMS protocol is efficient in the treatment of the Negative Symptoms of schizophrenia.
Neuroimaging studies demonstrate that hypoactivity in the left dorsolateral prefrontal cortex (LDLPFC) was associated with negative symptoms.
The investigators hypothesize that iTBS applied to LDLPFC will improve negative symptoms and will improve activity of the LDLPFC measured with Magnetic Resonance Spectroscopy (MRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active iTBS | Active comparator | Procedure: active iTBSiTBS active intensity = 80%MT during 6 minutes. 20 sessions, 2 per day |
| sham iTBS | Placebo comparator | Procedure: sham iTBSiTBS placebo (placebo coil)with same parameters than active |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Schizophrenia according to DSM-IV
- Negative symptoms for at least 6 weeks
- Medication resistance according to Kane et al., 1988
- Age between 18 and 50 years old
- Informed consent
Key exclusion criteria (2 listed)
- Contraindication to TMS
- Pregnancy
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 |
|---|---|---|
| active iTBSAlso: TMS, rTMS, TBS, iTBSIntermittent Theta Burst Stimulation (iTBS) over Left dorsolateral prefrontal cortex. 80% MT, 20 sessions of 6 minutes, 2 per day | Procedure or surgery | active iTBS |
| sham iTBSAlso: placebo TMS, placebo rTMSiTBS placebo (placebo coil) | Procedure or surgery | sham iTBS |
Primary outcome
Scale for the Assessment of Negative Symptoms (SANS)
Time frame: before, after 2 weeks of treatment, and 3 times follow-up (1, 3 and 6 months)
1 secondary outcome
Neurochemical impact of treatment measured by 1H-MRS, DTI and resting MRI
Time frame: 3 times, before treatment, immediatly after treatment and a last evaluation 3 months after
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 27 Jan 2016.
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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.
Emmanuel Poulet, MD, PhD principal investigator
Hopital Le Vinatier
JEROME BRUNELIN, PhD study director
Hopital le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active iTBS in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
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 5 inclusion and 2 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 27 Jan 2016. 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 France. 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.
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?
Scale for the Assessment of Negative Symptoms (SANS) (time frame: before, after 2 weeks of treatment, and 3 times follow-up (1, 3 and 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2016.