Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 27 for:    transcranial magnetic stimulation | Mild Cognitive Impairment

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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03983655
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Actipulse Neuroscience
Information provided by (Responsible Party):
Alberto José Mimenza Alvarado, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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
 (submitted: June 11, 2019)
Change from baseline ADAS-COG at 6 monts [ Time Frame: 6 months ]
Alzheimer´s Disease Assessment Scale-Cognitive
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • 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 ]
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.

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
Condition  ICMJE
  • Mild Cognitive Impairment
  • Mild Dementia
Intervention  ICMJE Device: High Frequency Low Intensity TMS
125 hz, 10 gauss, 2 times daily for 6 monts
Study Arms  ICMJE
  • 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.
    Intervention: Device: High Frequency Low Intensity TMS
  • 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.
    Intervention: Device: High Frequency Low Intensity TMS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alberto Mimenza, MD 54870-900 ext 5711 alberto.mimenzaa@incmnsz.mx
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP