HealthyNCT00416247
Effect of Hypnosis on Motor Cortex Excitability
A study testing Hypnosis in people with Healthy, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
This study is intended to investigate neurophysiological mechanisms of hypnosis using transcranial magnetic stimulation (TMS) and assessment of motor cortex excitability in healthy volunteers under hypnosis. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2006to Jun 2009
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged 20 to 45 years.
- Hypnotisability above 14 as measured by the Tellegan absorption scale.
Who cannot join
- Psychiatric diagnosis in axis I or axis II;
- Documented history of head injury or seizure disorder;
- Evidence of a disorder which could affect peripheral and central conduction such as multiple sclerosis, motor neuron disease, carpal tunnel syndrome, cervical spondylosis, diabetic neuropathy.
- Any other contraindication to TMS as specified in the safety guidelines for rTMS (Wassermann, 1998) such as cardiac pacemakers or metallic deep brain electrodes.
- Chronic pharmacological treatment.
Trial locations and contacts
1 site in 1 country.
About this study
This study is intended to investigate neurophysiological mechanisms of hypnosis using transcranial magnetic stimulation (TMS) and assessment of motor cortex excitability in healthy volunteers under hypnosis.
- Conditions
- Healthy
- Being tested
- Hypnosis
- Keywords
- Hypnosis, TMS, Cortical excitability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
Hypnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical Excitability
Measured: Before and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionDec 2007
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Ehud Klein, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416247
- Sponsor's protocol ID
- rambam2409_CTIL
- Status last verified
- Dec 2006
- First submitted
- 26 Dec 2006
- Last updated
- 5 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypnosis on Motor Cortex Excitability
- ClinicalTrials.gov ID
- NCT00416247
- Acronym / sponsor ID
- rambam2409_CTIL
- Conditions
- Healthy
- Keywords
- Hypnosis, TMS, Cortical excitability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 27 Dec 2006 (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.
This study is intended to investigate neurophysiological mechanisms of hypnosis using transcranial magnetic stimulation (TMS) and assessment of motor cortex excitability in healthy volunteers under hypnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers aged 20 to 45 years.
- Hypnotisability above 14 as measured by the Tellegan absorption scale.
Key exclusion criteria (5 listed)
- Psychiatric diagnosis in axis I or axis II;
- Documented history of head injury or seizure disorder;
- Evidence of a disorder which could affect peripheral and central conduction such as multiple sclerosis, motor neuron disease, carpal tunnel syndrome, cervical spondylosis, diabetic neuropathy.
- Any other contraindication to TMS as specified in the safety guidelines for rTMS (Wassermann, 1998) such as cardiac pacemakers or metallic deep brain electrodes.
- Chronic pharmacological treatment.
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 |
|---|---|---|
| HypnosisHypnosis | Behavioural | – |
Primary outcome
Cortical Excitability
Time frame: Before and after intervention
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 5 Aug 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.
Ehud Klein, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Healthy, run by Rambam Health Care Campus 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 5 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 5 Aug 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.
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?
Cortical Excitability (time frame: Before and after intervention). 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 Aug 2010.