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The Effect of Repeated Transcranial Magnetic Stimulation on Off-line Resting Electroencephalographic Signal in Alzheimer's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Amer Burhan, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01970150
First received: October 22, 2013
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to examine whether the rTMS (repetitive Transcranial Magnetic Stimulation) could change cortical excitability measured by off-line EEG in Alzheimer's Disease (AD) patients.


Condition Intervention
Alzheimer Disease
Device: rTMS real

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: To Investigate the Effect of Application of Repeated Trans-cranial Magnetic Stimulation (rTMS) Applied on the Left Prefrontal Cortex on Electroencephalography Signal Recorded From Brain Regions Involved in Cognitive Function in Patients With Alzheimer's Disease (AD)

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • A change in the quantitative EEG spectra in the frontal lobe, i.e. a change in percentage of theta waves, alpha and beta waves [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    We anticipate that rTMS exposure will result in a change in cortical excitability as evident by lowering the percentage of low frequency waves (delta and theta waves)in the cortical area under the stimulation site (left prefrontal cortex) and in functionally connected areas (contralateral cortex, inferior parietal cortex)as assessed by the EEG waves after 4 weeks of rTMS treatment.


Secondary Outcome Measures:
  • Improvement on memory and attention [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    We will explore the potential for improvement in memory and/or attention as asessed by MoCA and the Trail Making Test Part A and the Trail Making Test Part B, after 4 weeks of rTMS treatment.


Estimated Enrollment: 15
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
In this intervention patients receive 5 days a week for 4 weeks of rTMS treatment with real coil
Device: rTMS real
Other Name: Magstim Super Rapid 2

Detailed Description:

Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of 21 sessions of rTMS over the course of four weeks.During the first visit, they will be asked to undergo 1 hour of EEG (Electroencephalograph) before they start the repetitive transcranial magnetic stimulation sessions (rTMS), 0.5-hour of memory testing using MoCA and Trail Making Test (Trial A and B), 1 hour of rTMS and 1 hour of EEG after rTMS. The second visit will start approximately 24-72 hours after the first visit. During visit 2 to visit 20, participants will receive about 1 hour of TMS session 5 days a week for 4 weeks. During the 21st visit, which will be approximately one day after the last TMS session, participants will be asked to repeat 1 hour of EEG before TMS; 0.5-hour of memory testing using MoCA and Trail Making Test (Trial A and B), 1 hour TMS and 1 hour of EEG after TMS. For this study, a questionnaire concerning any potential side effects will be administrated before and after each session.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females,
  • Age 55-85 years old,
  • Able to consent and agrees to participate (if patient does not have capacity to give a consent then a caregiver will be asked )
  • Fluent in English
  • Diagnosed with probable AD (NINCDS-ADRDA criteria) mild stage as defined by a composite score of 1 or less on clinical dementia rating scale (CDR)

Exclusion Criteria:

  • Other neurological illness that would interfere with cognitive function (significant stroke, seizure d/o, Parkinson, Huntington etc.).
  • Psychiatric illness known to affect cognition such as schizophrenia/schizo-affective disorder, substance use disorder within 1 year of study, active depression or anxiety disorder or history of recurrent major mood disorder prior to cognitive change.
  • Medications: benzodiazepines will be exclusionary. Other psychotropic medications including Acetyl Choline Esterase inhibitors will be allowed but the dose needs to be stable for at least one month prior to the start and during the study. Patients taking medications that might increase the risk of seizures should not participate in the study.
  • Subjects with metal anywhere in the head, excluding the mouth, is generally a contraindication to TMS. This includes shrapnel, and screws and clips from surgical procedures unless the physical properties of the metal object are known and there is a strong reason for using TMS.
  • Subjects with cardiac pacemakers and implanted medication pumps should not participate in most TMS studies.
  • TMS also should not be performed in patients with electrodes inside the heart which might provide a low-resistance current path to electrically sensitive tissue.
  • Persons with serious heart disease are at increased risk in the event of a seizure,
  • Persons with increased intracranial pressure, as in acute large infarctions or trauma, are also at increased risk in the event of a seizure, and should not receive TMS.
  • Pregnant women or women in child bearing age that might be pregnant.
  • Patients who are already enrolled in another study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970150

Contacts
Contact: Amer Burhan, MD 519-455-5110 ext 47326 amer.burhan@sjhc.london.on.ca

Locations
Canada, Ontario
Regional Mental Health Care London Recruiting
London, Ontario, Canada, N6A 4H1
Contact: Amer Burhan, MD    519-455-5110 ext 47326    amer.burhan@sjhc.london.on.ca   
Contact: Luljeta Pallaveshi, BA    519-455-5110 ext 47762    luli.pallaveshi@sjhc.london.on.ca   
Principal Investigator: Amer Burhan, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Amer Burhan, MD University of Western Ontario, Canada
  More Information

Publications:
Responsible Party: Amer Burhan, Psychiatrist, Assistant Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01970150     History of Changes
Other Study ID Numbers: 104382
Study First Received: October 22, 2013
Last Updated: March 17, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Lawson Health Research Institute:
rTMS
Alzheimer Disease
Memory
attention
EEG

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 20, 2014