Healthy VolunteersEarly Phase 1NCT00912522
Magnetic Prefrontal Stimulation for Studying the Role of the Cortex in High-level Cognition Processes and Reward System
A Early Phase 1 study testing TMS in people with Healthy Volunteers, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The investigators intend to study the role of the cortex in high- level cognition processes and sensory adaptation, by the use of non-invasive Transcranial Magnetic stimulation and various cognitive tests. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2009to Jun 2014
- Phase
- Early 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men and women, age of 18-60
- answered negatively to questions of TMS safety questionnaire
- signed and declared about their agreement to participate in the study
- hebrew speaker
Who cannot join
- self history of significant mental disorder
- self history or first-degree relatives history of epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
The investigators intend to study the role of the cortex in high- level cognition processes and sensory adaptation, by the use of non-invasive Transcranial Magnetic stimulation and various cognitive tests.
- Conditions
- Healthy Volunteers
- Being tested
- TMS
- Keywords
- reward, TMS, cognition, Motivation, Perception, Decision making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
TRANSCRANIAL MAGNETIC STIMULATION
| Study group | Role | What they receive |
|---|---|---|
| LT PFC HIGH FREQ TMS | Active comparator | Not described Receives: Device: TMS |
| LT PFC LOW FREQ TMS | Active comparator | Not described Receives: Device: TMS |
| RT PFC HIGH FREQ TMS | Active comparator | Not described Receives: Device: TMS |
| RT PFC LOW FREQ TMS | Active comparator | Not described Receives: Device: TMS |
| SHAM STIMULATION | Sham comparator | Not described Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in scoring of different tests and questionnaires
Measured: One year
Secondary outcomes (1)
Correlation of different tests and questionnaires
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Principal investigator, Moshe Isserles, Hadassah Medical Organization
- Investigators
- Moshe Isserles, Dr., Principal investigator, Hadassa Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912522
- Sponsor's protocol ID
- 0116-09-HMO-CTIL
- Status last verified
- Apr 2015
- First submitted
- 2 Jun 2009
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Prefrontal Stimulation for Studying the Role of the Cortex in High-level Cognition Processes and Reward System
- ClinicalTrials.gov ID
- NCT00912522
- Acronym / sponsor ID
- 0116-09-HMO-CTIL
- Conditions
- Healthy Volunteers
- Keywords
- reward, TMS, cognition, Motivation, Perception, Decision making
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- Jun 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 Jun 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 investigators intend to study the role of the cortex in high- level cognition processes and sensory adaptation, by the use of non-invasive Transcranial Magnetic stimulation and various cognitive tests.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LT PFC HIGH FREQ TMS | Active comparator | Device: TMS |
| LT PFC LOW FREQ TMS | Active comparator | Device: TMS |
| RT PFC HIGH FREQ TMS | Active comparator | Device: TMS |
| RT PFC LOW FREQ TMS | Active comparator | Device: TMS |
| SHAM STIMULATION | Sham comparator | Device: TMS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy men and women, age of 18-60
- answered negatively to questions of TMS safety questionnaire
- signed and declared about their agreement to participate in the study
- hebrew speaker
Key exclusion criteria (2 listed)
- self history of significant mental disorder
- self history or first-degree relatives history of epilepsy
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 |
|---|---|---|
| TMSTRANSCRANIAL MAGNETIC STIMULATION | Device | LT PFC HIGH FREQ TMS, LT PFC LOW FREQ TMS, RT PFC HIGH FREQ TMS, RT PFC LOW FREQ TMS, SHAM STIMULATION |
Primary outcome
Changes in scoring of different tests and questionnaires
Time frame: One year
1 secondary outcome
Correlation of different tests and questionnaires
Time frame: One year
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 22 Apr 2015.
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Screening Protocol
Pain
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.
Moshe Isserles, Dr. principal investigator
Hadassa Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TMS in people with Healthy Volunteers, run by Hadassah Medical Organization 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 4 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 22 Apr 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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.
What does the primary outcome measure?
Changes in scoring of different tests and questionnaires (time frame: One 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 22 Apr 2015.