Alzheimer's DiseasePhase 2TMS in ADNCT00753662
Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease
A Phase 2 study testing 1Hz TMS with H2 coil and 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex in people with Alzheimer's Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H2 coil to prefrontal and parieto-temporal cortex to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- 1Hz TMS with H2 coil and 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Nov 2012
- Phase
- Phase 2
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent will be obtained
- diagnostic evidence of probable AD consistent with DSM IV
- stable treatment with Acetylcholine-Esterase Inhibitors or/and Memantine for 5 weeks prior to screening
- stable dose treatment with other drugs
- MMSE <25
Who cannot join
- Patients with neurological or psychiatric disorders that affect cognition but are distinguishable from AD
- Patients who are unwilling or unable to fulfill the requirements of the study
- Severe personality disorder
- Malignant or untreated Hypertension
- History of Epilepsy
- History of Head trauma
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- Metal implant in head, cardiac pacemaker, medical pump
- Drug or alcohol addiction
- Involvement in any other clinical trial during the preceding 3 month
- Patient who are unwilling or unable to give Informed Consent
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center, Neurology Department
Tel Aviv, 64239
Alissa Ash, Dr., 972-3-6973698, elissaa@tasmc.health.gov.il
About this study
Official title: Phase 2 (Feasibility) Study of Transcranial Magnetic Stimulation as Additional Therapy to Drug Treatment in Patients With Alzheimer's Disease
The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H2 coil to prefrontal and parieto-temporal cortex to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.
Read the detailed description
Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C, Neuropsychological computerized test (Mindstream), FAB,ADL, Beck Depression Inventory-time frame baseline,1 month (visit 12) 2 months (visit 16), 4 months (visit 17).
Estimated enrollment: 45 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2012 Number of arms: 3 Interventions details: H2 coil device for Transcranial Magnetic Stimulation with MAGSTIM to prefrontal and parieto-temporal regions bilaterally with frequency 10Hz in one arm, 1Hz in the second arm, and sham-stimulation with frequency 10Hz/1Hz in third arm.
Ages: 50-80 Genders: both
- Conditions
- Alzheimer's Disease
- Being tested
- 1Hz TMS with H2 coil, 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex, SHAM TMS with H2 coil
- Keywords
- TMS AD H2 coil
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1Hz TMS with H2 coilDevice
1Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
10Hz TMS with H2 coil to prefrontal and parieto-temporal cortexDevice
Also called 10Hz TMS with H2 coil
10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
SHAM TMS with H2 coilDevice
SHAM TMS with H2 coil to prefrontal and parieto-temporal cortex
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 15 patients in group 1 will be treated with 1Hz frequency Receives: Device: 1Hz TMS with H2 coil |
| 2 | Active comparator | 15 patients in group 2 will be treated with 1Hz frequency 10Hz Receives: Device: 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex |
| 3 | Sham comparator | 15 patients in group 3 will be treated with SHAM (1Hz/10Hz) Receives: Device: SHAM TMS with H2 coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-COG
Measured: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)
Secondary outcomes (1)
CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory.
Measured: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Brainsway
- Responsible party
- Principal investigator, Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
- Investigators
- Alissa Ash, Dr., Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753662
- Sponsor's protocol ID
- TASMC-08-AA-0397-CTIL
- Acronym
- TMS in AD
- Status last verified
- Sep 2011
- First submitted
- 14 Sep 2008
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 (Feasibility) Study of Transcranial Magnetic Stimulation as Additional Therapy to Drug Treatment in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00753662
- Acronym / sponsor ID
- TMS in AD / TASMC-08-AA-0397-CTIL
- Conditions
- Alzheimer's Disease
- Keywords
- TMS AD H2 coil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Brainsway
- Study start
- Nov 2008
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 16 Sep 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.
The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H2 coil to prefrontal and parieto-temporal cortex to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.
Detailed description
Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C, Neuropsychological computerized test (Mindstream), FAB,ADL, Beck Depression Inventory-time frame baseline,1 month (visit 12) 2 months (visit 16), 4 months (visit 17).
Estimated enrollment: 45 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2012 Number of arms: 3 Interventions details: H2 coil device for Transcranial Magnetic Stimulation with MAGSTIM to prefrontal and parieto-temporal regions bilaterally with frequency 10Hz in one arm, 1Hz in the second arm, and sham-stimulation with frequency 10Hz/1Hz in third arm.
Ages: 50-80 Genders: both
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: 1Hz TMS with H2 coil15 patients in group 1 will be treated with 1Hz frequency |
| 2 | Active comparator | Device: 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex15 patients in group 2 will be treated with 1Hz frequency 10Hz |
| 3 | Sham comparator | Device: SHAM TMS with H2 coil15 patients in group 3 will be treated with SHAM (1Hz/10Hz) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent will be obtained
- diagnostic evidence of probable AD consistent with DSM IV
- stable treatment with Acetylcholine-Esterase Inhibitors or/and Memantine for 5 weeks prior to screening
- stable dose treatment with other drugs
- MMSE <25
Key exclusion criteria (10 listed)
- Patients with neurological or psychiatric disorders that affect cognition but are distinguishable from AD
- Patients who are unwilling or unable to fulfill the requirements of the study
- Severe personality disorder
- Malignant or untreated Hypertension
- 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 |
|---|---|---|
| 1Hz TMS with H2 coil1Hz TMS with H2 coil to prefrontal and parieto-temporal cortex | Device | 1 |
| 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortexAlso: 10Hz TMS with H2 coil10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex | Device | 2 |
| SHAM TMS with H2 coilSHAM TMS with H2 coil to prefrontal and parieto-temporal cortex | Device | 3 |
Primary outcome
ADAS-COG
Time frame: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)
1 secondary outcome
CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory.
Time frame: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2011.
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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.
Alissa Ash, Dr. principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1Hz TMS with H2 coil and 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex in people with Alzheimer's Disease, run by Tel-Aviv Sourasky Medical 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 5 inclusion and 10 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 13 Sep 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Alissa Ash, Dr. (+972-3-6973698, 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?
ADAS-COG (time frame: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)). 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 13 Sep 2011.