SchizophreniaPhase 1NCT00445926
Evaluation of the H1-coil Deep TMS in the Treatment of Negative Symptoms and Cognitive Deficit in Schizophrenia
A Phase 1 study testing deep TMS H-coil in people with Schizophrenia, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
The study evaluates the feasibility of using a 4 week stimulation protocol with the deep TMS H-coils for the treatment of negative symptoms and cognitive deficit in schizophrenia patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- deep TMS H-coil
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jul 2006to May 2009
- Phase
- Phase 1
- 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
- DSM IV Diagnosis of Schizophrenia
- PANNS Negative > 21
Who cannot join
- risk factors for convulsions
- PANNS positive > 24
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep TMS With the H Coils as a Novel Strategy for the Treatment of Negative Symptoms of Schizophrenia
The study evaluates the feasibility of using a 4 week stimulation protocol with the deep TMS H-coils for the treatment of negative symptoms and cognitive deficit in schizophrenia patients
- Conditions
- Schizophrenia
- Being tested
- deep TMS H-coil
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep TMS H-coilDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startJul 2006
- Primary completionMay 2009
- Study completionMay 2009
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Investigators
- Eiran V Harel, MD, Principal investigator, Shalvata MHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445926
- Sponsor's protocol ID
- SH-40206
- Status last verified
- May 2010
- First submitted
- 8 Mar 2007
- Last updated
- 6 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep TMS With the H Coils as a Novel Strategy for the Treatment of Negative Symptoms of Schizophrenia
- ClinicalTrials.gov ID
- NCT00445926
- Acronym / sponsor ID
- SH-40206
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 9 Mar 2007 (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 study evaluates the feasibility of using a 4 week stimulation protocol with the deep TMS H-coils for the treatment of negative symptoms and cognitive deficit in schizophrenia patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DSM IV Diagnosis of Schizophrenia
- PANNS Negative > 21
Key exclusion criteria (2 listed)
- risk factors for convulsions
- PANNS positive > 24
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 |
|---|---|---|
| deep TMS H-coil | Device | – |
Primary outcome
Not reported in the source record.
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 6 May 2010.
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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.
Eiran V Harel, MD principal investigator
Shalvata MHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing deep TMS H-coil in people with Schizophrenia, run by Shalvata Mental Health Center at 1 site 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 2 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 6 May 2010. 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 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 6 May 2010.