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Effect of High Frequency/Low Intensity Transcranial Magnetic Stimulation in Cognitive Traits of an Elderly Population of Subjects With Mild Cognitive Impairment and Mild Dementia.
There are no pharmacological interventions that delay or prevent the transition of mild cognitive impairment to dementia. Several studies have shown that transcranial magnetic stimulation (TMS) could be useful in increasing cognitive traits in dementia.
As TMS is performed in a clinical setting, transportation, mobility and high costs of treatment, limit the number of TMS sessions dementia patients can receive. Most of the trials do not apply more than 20 TMS sessions
Here, a randomized, sham controlled, paralallel group, clinical trial will be performed in order to asess the efficacy at improving cognitive traits of a novel TMS device that uses high frequency and low intensity pulses. As the device is portable and can be used from home without clinical supervision, the stimulation will be applied two times per day for a period of 6 months.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mild Cognitive Impairment Mild Dementia | Device: High Frequency Low Intensity TMS | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of High Frequency/Low Intensity Transcranial Magnetic Stimulation in Cognitive Traits of an Elderly Population of Subjects With Mild Cognitive Impairment and Mild Dementia: A Randomized, Double Blind, Parallel Group, Sham Controlled Clinical Trial |
| Actual Study Start Date : | May 17, 2019 |
| Estimated Primary Completion Date : | May 17, 2020 |
| Estimated Study Completion Date : | August 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Real High Frequency Low Intensity TMS
Two sessions of transcranial magnetic stimulation each day for 6 monts. The coil of the device emits a pulsed magnetic field at an aproximate frequency of 125 hz and an intensity of 10 gauss.
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Device: High Frequency Low Intensity TMS
125 hz, 10 gauss, 2 times daily for 6 monts
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Sham Comparator: Sham High Frequency Low Intensity TMS
Two sessions of transcranial magnetic stimulation each day for 6 monts. The coil of the device does not emit a magnetic field.
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Device: High Frequency Low Intensity TMS
125 hz, 10 gauss, 2 times daily for 6 monts
|
- Change from baseline ADAS-COG at 6 monts [ Time Frame: 6 months ]Alzheimer´s Disease Assessment Scale-Cognitive
- Change from baseline of total Katz Index of Independence in Activities of Daily Living at 3 months [ Time Frame: 3 months ]
- Change from baseline of total Katz Index of Independence in Activities of Daily Living at 6 months [ Time Frame: 6 months ]
- Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 3 months [ Time Frame: 3 months ]
- Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 6 months [ Time Frame: 6 months ]
- Change from baseline of total Geriatric Depression Scale at 3 months [ Time Frame: 3 months ]
- Change from baseline of total Geriatric Depression Scale at 6 months [ Time Frame: 6 months ]
- Change from baseline of total Montreal Cognitive Assessment at 3 months [ Time Frame: 3 months ]
- Change from baseline of total Montreal Cognitive Assessment at 6 monts [ Time Frame: 6 months ]
- Change from baseline of total Frontal Asessment Battery at 3 monts [ Time Frame: 3 months ]
- Change from baseline Frontal Asessment Battery at 6 monts [ Time Frame: 6 months ]
| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
IInclusion Criteria:
( - ) CDR less or equal to 1 ( - ) Mild cognitive impairment by Petersen criteria ( - ) Conserved or corrected sight ( - ) Enrolled at INCMNSZ for medical care ( - ) Be able to read and write ( - ) Willing and able to provide written informed consent
Exclusion Criteria:
( - ) Other neurodegenerative disorder different than mild cognitive impairment or mild dementia ( - ) Metabolic disease without medical care ( - ) Epilepsy ( - ) Deep brain stimulator ( - ) Metalic prosthethics in the skulls ( - ) Major depressive disorder ( - ) Previous utilization of other neuromodulation technique ( - ) Signs or symptoms of increased intracraneal pressure
| Contact: Alberto Mimenza, MD | 54870-900 ext 5711 | alberto.mimenzaa@incmnsz.mx |
| Mexico | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Recruiting |
| Mexico City, Mexico, 14080 | |
| Contact: Alberto Mimenza, MD 54870-900 ext 5711 alberto.mimenzaa@incmnsz.mx | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 21, 2019 | ||||
| First Posted Date ICMJE | June 12, 2019 | ||||
| Last Update Posted Date | June 12, 2019 | ||||
| Actual Study Start Date ICMJE | May 17, 2019 | ||||
| Estimated Primary Completion Date | May 17, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change from baseline ADAS-COG at 6 monts [ Time Frame: 6 months ] Alzheimer´s Disease Assessment Scale-Cognitive
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of High Frequency/Low Intensity Transcranial Magnetic Stimulation in Cognitive Traits of an Elderly Population of Subjects With Mild Cognitive Impairment and Mild Dementia. | ||||
| Official Title ICMJE | Effect of High Frequency/Low Intensity Transcranial Magnetic Stimulation in Cognitive Traits of an Elderly Population of Subjects With Mild Cognitive Impairment and Mild Dementia: A Randomized, Double Blind, Parallel Group, Sham Controlled Clinical Trial | ||||
| Brief Summary |
There are no pharmacological interventions that delay or prevent the transition of mild cognitive impairment to dementia. Several studies have shown that transcranial magnetic stimulation (TMS) could be useful in increasing cognitive traits in dementia. As TMS is performed in a clinical setting, transportation, mobility and high costs of treatment, limit the number of TMS sessions dementia patients can receive. Most of the trials do not apply more than 20 TMS sessions Here, a randomized, sham controlled, paralallel group, clinical trial will be performed in order to asess the efficacy at improving cognitive traits of a novel TMS device that uses high frequency and low intensity pulses. As the device is portable and can be used from home without clinical supervision, the stimulation will be applied two times per day for a period of 6 months. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: High Frequency Low Intensity TMS
125 hz, 10 gauss, 2 times daily for 6 monts
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| Study Arms ICMJE |
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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 | Unknown status | ||||
| Estimated Enrollment ICMJE |
80 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | August 1, 2020 | ||||
| Estimated Primary Completion Date | May 17, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
IInclusion Criteria: ( - ) CDR less or equal to 1 ( - ) Mild cognitive impairment by Petersen criteria ( - ) Conserved or corrected sight ( - ) Enrolled at INCMNSZ for medical care ( - ) Be able to read and write ( - ) Willing and able to provide written informed consent Exclusion Criteria: ( - ) Other neurodegenerative disorder different than mild cognitive impairment or mild dementia ( - ) Metabolic disease without medical care ( - ) Epilepsy ( - ) Deep brain stimulator ( - ) Metalic prosthethics in the skulls ( - ) Major depressive disorder ( - ) Previous utilization of other neuromodulation technique ( - ) Signs or symptoms of increased intracraneal pressure |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 65 Years and older (Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Mexico | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03983655 | ||||
| Other Study ID Numbers ICMJE | GER-2962-19-20-1 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Alberto José Mimenza Alvarado, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | ||||
| Study Sponsor ICMJE | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | ||||
| Collaborators ICMJE | Actipulse Neuroscience | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | ||||
| Verification Date | June 2019 | ||||
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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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