Mild Cognitive ImpairmentPhase 1NCT01464515
Efficiency of Deep Transcranial Magnetic Stimulation on Patients With Mild Cognitive Impairment
A Phase 1 study testing H-Coil Deep TMS in people with Mild Cognitive Impairment, run by Brainsway at 1 site in Israel.
Trial summary
This is a first feasibility study in order to test if deep Transcranial Magnetic Stimulation (TMS) treatment with high frequency (10Hz) will improve the symptoms of patient MCI (Mild Cognitive impairment). Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- H-Coil Deep TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2021to Jan 2021
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 50-80 years of age.
- Self reporting of the patient about memory deterioration, without any damage of daily lify functioning.
- Scored of one standard deviation below the average (according to standardization of age and years of schooling) in the memory index and Mindstream test, without any major damage of other cognitive function)
- score >= 24 in MMSE (Mini Mental State Examination) test.
- Preserved Cognitive and executive functioning, without dementia according to DSM -IV
- Lack of other reason for memory deterioration like acute affect disorder or other neurological disorders, according to the doctor diagnosis.
- Score of maximum 0.5 in the Clinical Dementia Rating. in this test the score of the memory index will be 0.5 or 1, and not more then 1 point in two other index of this test.
- Capable and willing to provide informed consent.
Who cannot join
- Any other Axis I diagnosis as the primary diagnosis
- Any medications that can cause a risk of seizure. for instance, anti psychotic medication, high dosage of anti depression medication
- History of non tolerance for TMS treatment
- Diagnosis of Severe personality disorder according to DSM-IV
- current suicidal tendency
- Uncontrolled hypertension
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- History of epilepsy, seizure, or heat convulsion
- History of epilepsy or seizure in first degree relatives
- History of head injury or stroke
- History of metal implants in the head (except dental fillings)
- History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps
- History of drug or alcohol abuse
- Inadequate communication with examiner
- Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it
- Inability to sign a consent form
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ichilov Hospital, Neurological Department
Tel Aviv
Elissa Ash, Dr., +97236973698, elissaa@tasmc.health.gov.il
About this study
Official title: Feasibility Study in Order to Test the Efficiency of Deep TMS on Patient With MCI
This is a first feasibility study in order to test if deep Transcranial Magnetic Stimulation (TMS) treatment with high frequency (10Hz) will improve the symptoms of patient MCI (Mild Cognitive impairment). The hypothesis of the study is that high frequency treatment with deep TMS will improve the daily functioning of patients who suffers from MCI.
- Conditions
- Mild Cognitive Impairment
- Being tested
- H-Coil Deep TMS, SHAM Coil TMS
- Keywords
- Mild Cognitive Impairment, So Stated, Deep Transcranial Magnetic Stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-Coil Deep TMSDevice
this group will receive high frequency treatment of deep TMS with 10Hz
SHAM Coil TMSDevice
this group will receive SHAM treatment of deep TMS
| Study group | Role | What they receive |
|---|---|---|
| Real TMS | Active comparator | this group will receive high frequency deep TMS treatment of 10HZ Receives: Device: H-Coil Deep TMS |
| SHAM TMS | Sham comparator | this group will receive SHAM treatment of deep TMS Receives: Device: SHAM Coil TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindstreams
Mindstreams test is designed to test the I.Q change of the patients from baseline
Measured: the test will be assessed on visit 17 which means 4 month from baseline
Secondary outcomes (1)
CDR - Clinical Dementia Rating
CDR test is designed to test the dementia severity of the patients from baseline
Measured: the test will be assessed on visit 17 which means 4 month from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startJan 2021 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elissa Ash, Dr., Principal investigator, Ichilov Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464515
- Sponsor's protocol ID
- P-0021
- Status last verified
- Jan 2020
- First submitted
- 25 Oct 2011
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study in Order to Test the Efficiency of Deep TMS on Patient With MCI
- ClinicalTrials.gov ID
- NCT01464515
- Acronym / sponsor ID
- P-0021
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, So Stated, Deep Transcranial Magnetic Stimulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 3 Nov 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.
This is a first feasibility study in order to test if deep Transcranial Magnetic Stimulation (TMS) treatment with high frequency (10Hz) will improve the symptoms of patient MCI (Mild Cognitive impairment). The hypothesis of the study is that high frequency treatment with deep TMS will improve the daily functioning of patients who suffers from MCI.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real TMS | Active comparator | Device: H-Coil Deep TMSthis group will receive high frequency deep TMS treatment of 10HZ |
| SHAM TMS | Sham comparator | Device: SHAM Coil TMSthis group will receive SHAM treatment of deep TMS |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women 50-80 years of age.
- Self reporting of the patient about memory deterioration, without any damage of daily lify functioning.
- Scored of one standard deviation below the average (according to standardization of age and years of schooling) in the memory index and Mindstream test, without any major damage of other cognitive function)
- score >= 24 in MMSE (Mini Mental State Examination) test.
- Preserved Cognitive and executive functioning, without dementia according to DSM -IV
Key exclusion criteria (16 listed)
- Any other Axis I diagnosis as the primary diagnosis
- Any medications that can cause a risk of seizure. for instance, anti psychotic medication, high dosage of anti depression medication
- History of non tolerance for TMS treatment
- Diagnosis of Severe personality disorder according to DSM-IV
- current suicidal tendency
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 |
|---|---|---|
| H-Coil Deep TMSthis group will receive high frequency treatment of deep TMS with 10Hz | Device | Real TMS |
| SHAM Coil TMSthis group will receive SHAM treatment of deep TMS | Device | SHAM TMS |
Primary outcome
Mindstreams
Time frame: the test will be assessed on visit 17 which means 4 month from baseline
Mindstreams test is designed to test the I.Q change of the patients from baseline
1 secondary outcome
CDR - Clinical Dementia Rating
Time frame: the test will be assessed on visit 17 which means 4 month from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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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.
Elissa Ash, Dr. principal investigator
Ichilov Hospital
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 H-Coil Deep TMS in people with Mild Cognitive Impairment, run by Brainsway 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 8 inclusion and 16 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 14 Jul 2020. 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?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ellisa Ash, Dr. (+97236973698, elissaa@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindstreams (time frame: the test will be assessed on visit 17 which means 4 month from baseline). 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 14 Jul 2020.