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

NCT01970150 | Terminated

• 1 other identifier: 104382
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

rTMS; Alzheimer Disease; Memory; attention; EEG

Outcome Measures

Primary Outcomes (1)

• A change in the quantitative EEG spectra in the frontal lobe, i.e. a change in percentage of theta waves, alpha and beta waves

  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.

  4 weeks

Secondary Outcomes (1)

• Improvement on memory and attention

  4 weeks

Study Arms (1)

1

EXPERIMENTAL

In this intervention patients receive 5 days a week for 4 weeks of rTMS treatment with real coil

Device: rTMS real

Interventions

rTMS real DEVICE

Also known as: Magstim Super Rapid 2

1

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Regional Mental Health Care London

London, Ontario, N6A 4H1, Canada

Location

Related Publications (4)

• Cotelli M, Manenti R, Cappa SF, Geroldi C, Zanetti O, Rossini PM, Miniussi C. Effect of transcranial magnetic stimulation on action naming in patients with Alzheimer disease. Arch Neurol. 2006 Nov;63(11):1602-4. doi: 10.1001/archneur.63.11.1602.

  PMID: 17101829 BACKGROUND

• Cotelli M, Manenti R, Cappa SF, Zanetti O, Miniussi C. Transcranial magnetic stimulation improves naming in Alzheimer disease patients at different stages of cognitive decline. Eur J Neurol. 2008 Dec;15(12):1286-92. doi: 10.1111/j.1468-1331.2008.02202.x.

  PMID: 19049544 BACKGROUND

• Gawel M, Zalewska E, Szmidt-Salkowska E, Kowalski J. The value of quantitative EEG in differential diagnosis of Alzheimer's disease and subcortical vascular dementia. J Neurol Sci. 2009 Aug 15;283(1-2):127-33. doi: 10.1016/j.jns.2009.02.332. Epub 2009 Mar 6.

  PMID: 19268969 BACKGROUND

• Schreiter Gasser U, Rousson V, Hentschel F, Sattel H, Gasser T. Alzheimer disease versus mixed dementias: an EEG perspective. Clin Neurophysiol. 2008 Oct;119(10):2255-9. doi: 10.1016/j.clinph.2008.07.216. Epub 2008 Sep 2.

  PMID: 18768349 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Amer Burhan, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist, Assistant Professor

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 25, 2013
• Study Start: February 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

CA (1)