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

Primary Purpose

Alzheimer Disease

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

rTMS real

About this trial

This is an interventional basic science trial for Alzheimer Disease focused on measuring rTMS, Alzheimer Disease, Memory, attention, EEG

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Regional Mental Health Care London

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

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

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

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.

Full Information

NCT ID

NCT01970150

First Posted

October 22, 2013

Last Updated

September 6, 2016

Sponsor

Lawson Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01970150

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Terminated

Why Stopped

New data from a published trial requires substantial change in study protocol no funding available to carry the study further

Study Start Date

February 2014 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lawson Health Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

rTMS, Alzheimer Disease, Memory, attention, EEG

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

rTMS real

Other Intervention Name(s)

Magstim Super Rapid 2

Primary Outcome Measure Information:

Title

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

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Improvement on memory and attention

Description

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.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amer Burhan, MD

Organizational Affiliation

Western University, Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

Regional Mental Health Care London

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4H1

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

17101829

Citation

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.

Results Reference

background

PubMed Identifier

19049544

Citation

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.

Results Reference

background

PubMed Identifier

19268969

Citation

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.

Results Reference

background

PubMed Identifier

18768349

Citation

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.

Results Reference

background

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

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