Efficiency of Deep Transcranial Magnetic Stimulation on Patients With Mild Cognitive Impairment
This study is not yet open for participant recruitment.
Verified November 2011 by Brainsway
Sponsor:
Brainsway
Information provided by (Responsible Party):
Brainsway
ClinicalTrials.gov Identifier:
NCT01464515
First received: October 25, 2011
Last updated: November 2, 2011
Last verified: November 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 25, 2011 | ||||
| Last Updated Date | November 2, 2011 | ||||
| Start Date ICMJE | November 2011 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mindstreams [ Time Frame: the test will be assessed on visit 17 which means 4 month from baseline ] [ Designated as safety issue: No ] Mindstreams test is designed to test the I.Q change of the patients from baseline |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01464515 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
CDR - Clinical Dementia Rating [ Time Frame: the test will be assessed on visit 17 which means 4 month from baseline ] [ Designated as safety issue: No ] CDR test is designed to test the dementia severity of the patients from baseline |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficiency of Deep Transcranial Magnetic Stimulation on Patients With Mild Cognitive Impairment | ||||
| Official Title ICMJE | Feasibility Study in Order to Test the Efficiency of Deep TMS on Patient With MCI | ||||
| Brief 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). The hypothesis of the study is that high frequency treatment with deep TMS will improve the daily functioning of patients who suffers from MCI. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
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| Condition ICMJE | Mild Cognitive Impairment | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | November 2012 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 55 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01464515 | ||||
| Other Study ID Numbers ICMJE | P-0021 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Brainsway | ||||
| Study Sponsor ICMJE | Brainsway | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Brainsway | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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