SchizophreniaNCT00685321
Tolerability, Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia
A study testing H1 deep TMS coil in people with Schizophrenia, run by Shalvata Mental Health Center at 2 sites in Israel.
Trial summary
Objectives:The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with negative symptoms and cognitive deficits of schizophrenia (deficit syndrome), currently treated with atypical antipsychotics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- H1 deep TMS coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesIsrael
- Study dates
- Jun 2008to Jan 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18-65 (male and female), Diagnosed in the past as suffering from schizophrenia. The diagnosis will be reaffirmed according to ICD criteria.
- Right hand dominant.
- Scores in PANSS negative questionnaire above 21.
- Gave informed consent for participation in the study.
- Negative answers on safety screening questionnaire for transcranial magnetic stimulation
- stable on the same antipsychotic medication for at least two months prior to entering the study.
- Negative answers to all questions in the TMS safety questionnaire (attached ).
Who cannot join
- Diagnosed as suffering from another axis 1 disorder .
- Scores in PANSS positive questionnaire above 24.
- History of epilepsy, seizure, or hot spasm.
- History of epilepsy within first-degree relatives.
- History of head injuries.
- History of metal in the head (outside the mouth space).
Show all 15Show fewer
- History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
- History of migraines.
- History of hearing loss (not due to aging) or cochlear implants.
- History of drug or alcohol abuse during the last year.
- Women - Pregnancy or not using a reliable method of birth control.
- Inability to achieve satisfying level of communication with the subject.
- suicide attempt in the year prior to treatment or suicide risk according to a suicide questionnaire
- Custodians.
- Participation in another medical study during the experiment.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Shalvata Mental Helath Center
Hod HaSharon
Hilik Levkovitz, prof., 972-9-7478569, ylevk@clalit.org.il
- Not yet recruiting
Shalvata
Hod HaSharon
About this study
Official title: A Double Blind Randomized Controlled Trial to Explore the Tolerability, Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia
Objectives:The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with negative symptoms and cognitive deficits of schizophrenia (deficit syndrome), currently treated with atypical antipsychotics.
Patient Population: The intention is to treat 45 patients diagnosed with schizophrenia, who are currently suffering mainly from negative symptoms and cognitive deficits (deficit syndrome). The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age, and have PANSS negative≥21 and PANSS positive<24. Patients will be recruited from both academic and private research centers.
Read more
Structure: The study is a randomized, prospective, 8 weeks, double blind study. Blinding: The treatment administrator and the study personnel and patients will be masked to the treatment being administrated.
Concurrent Control: The study group will receive active rTMS treatment and the control group will receive an inactive, sham treatment.
- Conditions
- Schizophrenia
- Being tested
- H1 deep TMS coil, Sham
- Keywords
- schizophrenia, TMS, brain stimulation, negative symptoms, clinical improvement, cognitive improvement
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H1 deep TMS coilDevice
20 daily deep rTMS treatment
ShamDevice
inactive treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | deep TMS treatment Receives: Device: H1 deep TMS coil |
| 2 | Sham comparator | inactive treatment Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
SANS
Measured: 1.5 year
Secondary outcomes (1)
SOFAS
Measured: 1.5 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yechiel levkovitz, MD, Principal investigator, Shalvate mental health center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685321
- Sponsor's protocol ID
- 0024-07-SHA
- Status last verified
- Jan 2012
- First submitted
- 25 May 2008
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Controlled Trial to Explore the Tolerability, Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia
- ClinicalTrials.gov ID
- NCT00685321
- Acronym / sponsor ID
- 0024-07-SHA
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, TMS, brain stimulation, negative symptoms, clinical improvement, cognitive improvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 28 May 2008 (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.
Objectives:The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with negative symptoms and cognitive deficits of schizophrenia (deficit syndrome), currently treated with atypical antipsychotics.
Patient Population: The intention is to treat 45 patients diagnosed with schizophrenia, who are currently suffering mainly from negative symptoms and cognitive deficits (deficit syndrome). The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age, and have PANSS negative≥21 and PANSS positive<24. Patients will be recruited from both academic and private research centers.
Structure: The study is a randomized, prospective, 8 weeks, double blind study. Blinding: The treatment administrator and the study personnel and patients will be masked to the treatment being administrated.
Concurrent Control: The study group will receive active rTMS treatment and the control group will receive an inactive, sham treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: H1 deep TMS coildeep TMS treatment |
| 2 | Sham comparator | Device: Shaminactive treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients between the ages of 18-65 (male and female), Diagnosed in the past as suffering from schizophrenia. The diagnosis will be reaffirmed according to ICD criteria.
- Right hand dominant.
- Scores in PANSS negative questionnaire above 21.
- Gave informed consent for participation in the study.
- Negative answers on safety screening questionnaire for transcranial magnetic stimulation
Key exclusion criteria (15 listed)
- Diagnosed as suffering from another axis 1 disorder .
- Scores in PANSS positive questionnaire above 24.
- History of epilepsy, seizure, or hot spasm.
- History of epilepsy within first-degree relatives.
- History of head injuries.
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 |
|---|---|---|
| H1 deep TMS coil20 daily deep rTMS treatment | Device | 1 |
| Shaminactive treatment | Device | 2 |
Primary outcome
SANS
Time frame: 1.5 year
1 secondary outcome
SOFAS
Time frame: 1.5 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
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
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
yechiel levkovitz, MD principal investigator
Shalvate mental health center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H1 deep TMS coil in people with Schizophrenia, run by Shalvata Mental Health Center at 2 sites in Israel.
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 15 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 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact liron rabani, Phd. student (972-97478644, lironrab@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SANS (time frame: 1.5 year). 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 5 Jan 2012.