SchizophreniaPhase 2NCT01315587
Repetitive Transcranial Magnetic Stimulation and Intermittent Theta Burst (iTBS) in Schizophrenia
A Phase 2 study testing repetitive Transcranial Magnetic Stimulation (Magstim rapid2 ), repetitive Transcranial Magnetic Stimulation (Magstim rapid2) and repetitive Transcranial Magnetic Stimulation(Magstim rapid2) in people with Schizophrenia, run by University of Tehran at 1 site in Iran.
Trial summary
The pilot studies have showed that theta burst stimulation (TBS) can have the more rapid and durable effects to the apply traditional rTMS protocols. The aim of this study is to investigate the effect of repetitive TMS and theta burst in reduction of negative symptoms and remission of cognitive functioning in patients… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- repetitive Transcranial Magnetic Stimulation (Magstim rapid2 ), repetitive Transcranial Magnetic Stimulation (Magstim rapid2) and repetitive Transcranial Magnetic Stimulation(Magstim rapid2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Jan 2011to Jan 2017
- Phase
- Phase 2
- 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
- Outpatients male and female with the range of 18-50 years of age
- The diagnosis of schizophrenia according to DSM-IV-TR
- Completion of consent form
- Being under supervision of a psychiatrist,
- Being able to adhere to treatment schedule,
- Having stable symptoms as defined by not requiring a change in antipsychotic medication for at least 4 weeks or at least 2 weeks for psychotropic agents prior to entering the Study
Who cannot join
- The history of rTMS treatment for any reason
- Cardiac pacemaker
- Drug pumps
- Acute heart attack
- The risk of seizure with any reasons
- The history of epilepsy or seizure in the first relatives
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- Any metal in head
- Brain trauma
- Pregnancy
- Breastfeeding
- Drug dependency
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Atieh Clinical Neuroscience Center (ACNC)
Tehran, Tehran Province, 1969713663
Reza Rostami, MD, 009802184012101, rrostami@ut.ac.ir
Reza Rostami, MD
About this study
Official title: A Double-blind Placebo Controlled Trial the Comparison of Effectiveness of Repetitive TMS and iTBS on Negative Symptoms and Cognition in Patients With Schizophrenia
The pilot studies have showed that theta burst stimulation (TBS) can have the more rapid and durable effects to the apply traditional rTMS protocols. The aim of this study is to investigate the effect of repetitive TMS and theta burst in reduction of negative symptoms and remission of cognitive functioning in patients with schizophrenia. In a randomized, double blind clinical trials, 30 patients with schizophrenia in Razi psychiatric hospital will be assigned to receive repetitive TMS; theta burst, or sham TMS, daily; for 20 sessions. The negative symptoms and cognitive functioning will be assessed before the treatment (pre test) during the treatment (session 10), and after the treatment (post test).QEEG and LORETA apply before and after rTMS in all subjects.
- Conditions
- Schizophrenia
- Being tested
- repetitive Transcranial Magnetic Stimulation (Magstim rapid2 ), repetitive Transcranial Magnetic Stimulation (Magstim rapid2), repetitive Transcranial Magnetic Stimulation(Magstim rapid2)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )Device
Also called TMS, rTMS, TBS, iTBS
- 3 pulses at 50Hz repeated each 200 ms for 2 seconds
- 80% MT
- 20 days treatment
repetitive Transcranial Magnetic Stimulation (Magstim rapid2)Device
Also called TMS, rTMS
LDLPFC 110% MT 15 Hz 20 days
repetitive Transcranial Magnetic Stimulation(Magstim rapid2)Device
Placebo treatment: Sham coil
| Study group | Role | What they receive |
|---|---|---|
| intermittent theta burst stimulation | Active comparator | Not described Receives: Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2 ) |
| repetitive Transcranial Magnetic Stimulation | Active comparator | Not described Receives: Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2) |
| Sham TMS | Placebo comparator | Not described Receives: Device: repetitive Transcranial Magnetic Stimulation(Magstim rapid2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and negative syndrome scale ( PANSS )
Measured: Change of baseline in negative symptoms at 20 sessions
Secondary outcomes (4)
Calgary depression for schizophrenia scale (CDSS)
The CDSS is administered for measuring of depression before treatment, session 10, immediately after treatment
Measured: 3 times (Before treatment, session 10, immediately after treatment)
Schizophrenia quality of life scale (SQLS)
The SQLS is administered for apprising of quality of life before treatment, session 10, immediately after treatment.
Measured: 3 times (Before treatment, session 10, immediately after treatment)
Cantab Schizophrenia Battery
Cantab Schizophrenia Battery is included six tests, which is measuring for cognitive function. The cognitive function includes reaction time, executive function, Sustained attention, , Episodic memory . These scales:
Reaction time (RTI) Rapid Visual information processing (RVP) Spatial Working Memory (SWM) One Touch Stockings of Cambridge (OTS) Paired Associates Learning (PAL) Intra-Extra Dimensional set- Shift (IED)
Measured: 3 times (Before treatment, session 10, immediately after treatment)
QEEG and low resolution brain electromagnetic tomography (LORETA)
QEEG and LORETA is applying for assessment brain waves patterns.
Measured: 3 times (Before treatment,session 10, immediately after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2015 (estimated)
- Study completionJan 2017 (estimated)
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.
- 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, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tehran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, reza kazemi, University of Tehran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315587
- Sponsor's protocol ID
- 23456
- Status last verified
- Aug 2015
- First submitted
- 14 Mar 2011
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Placebo Controlled Trial the Comparison of Effectiveness of Repetitive TMS and iTBS on Negative Symptoms and Cognition in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01315587
- Acronym / sponsor ID
- 23456
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of TehranUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 15 Mar 2011 (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 pilot studies have showed that theta burst stimulation (TBS) can have the more rapid and durable effects to the apply traditional rTMS protocols. The aim of this study is to investigate the effect of repetitive TMS and theta burst in reduction of negative symptoms and remission of cognitive functioning in patients with schizophrenia. In a randomized, double blind clinical trials, 30 patients with schizophrenia in Razi psychiatric hospital will be assigned to receive repetitive TMS; theta burst, or sham TMS, daily; for 20 sessions. The negative symptoms and cognitive functioning will be assessed before the treatment (pre test) during the treatment (session 10), and after the treatment (post test).QEEG and LORETA apply before and after rTMS in all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intermittent theta burst stimulation | Active comparator | Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2 ) |
| repetitive Transcranial Magnetic Stimulation | Active comparator | Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2) |
| Sham TMS | Placebo comparator | Device: repetitive Transcranial Magnetic Stimulation(Magstim rapid2) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Outpatients male and female with the range of 18-50 years of age
- The diagnosis of schizophrenia according to DSM-IV-TR
- Completion of consent form
- Being under supervision of a psychiatrist,
- Being able to adhere to treatment schedule,
Key exclusion criteria (11 listed)
- The history of rTMS treatment for any reason
- Cardiac pacemaker
- Drug pumps
- Acute heart attack
- The risk of seizure with any reasons
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 (Magstim rapid2 )Also: TMS, rTMS, TBS, iTBS* 3 pulses at 50Hz repeated each 200 ms for 2 seconds * 80% MT * 20 days treatment | Device | intermittent theta burst stimulation |
| repetitive Transcranial Magnetic Stimulation (Magstim rapid2)Also: TMS, rTMSLDLPFC 110% MT 15 Hz 20 days | Device | repetitive Transcranial Magnetic Stimulation |
| repetitive Transcranial Magnetic Stimulation(Magstim rapid2)Placebo treatment: Sham coil | Device | Sham TMS |
Primary outcome
Positive and negative syndrome scale ( PANSS )
Time frame: Change of baseline in negative symptoms at 20 sessions
4 secondary outcomes
Calgary depression for schizophrenia scale (CDSS)
Time frame: 3 times (Before treatment, session 10, immediately after treatment)
Schizophrenia quality of life scale (SQLS)
Time frame: 3 times (Before treatment, session 10, immediately after treatment)
Cantab Schizophrenia Battery
Time frame: 3 times (Before treatment, session 10, immediately after treatment)
QEEG and low resolution brain electromagnetic tomography (LORETA)
Time frame: 3 times (Before treatment,session 10, immediately after treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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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.
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 (Magstim rapid2 ), repetitive Transcranial Magnetic Stimulation (Magstim rapid2) and repetitive Transcranial Magnetic Stimulation(Magstim rapid2) in people with Schizophrenia, run by University of Tehran at 1 site in Iran.
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 6 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: status not confirmed, as of the sponsor's last update on 1 Sep 2015. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reza kazemi, PhD (009802184012128, rezakazemi@ut.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and negative syndrome scale ( PANSS ) (time frame: Change of baseline in negative symptoms at 20 sessions). 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 1 Sep 2015.