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

NCT ID: NCT01970150

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-04-30

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.

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

rTMS real

Intervention Type: DEVICE

Interventions

rTMS real

Intervention Type: DEVICE

Other Intervention Names

Magstim Super Rapid 2

Eligibility 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Amer Burhan

Psychiatrist, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amer Burhan, MD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

Regional Mental Health Care London

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 17101829 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19049544 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19268969 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18768349 (View on PubMed)

Other Identifiers

104382

Identifier Type: -

Identifier Source: org_study_id