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Effects of rTMS on the Cognition of Elderly With Mild Memory Complaints (TMSMemOld)

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Elderly, Memory, Cognition, Repetitive transcranial magnetic stimulation

Eligibility Criteria

60 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants of both sexes
  • Aged between 60 and 74 years
  • Schooling ≥ 4 years
  • Performance on neuropsychological tests of up to 1.5 standard deviations below normal for age and education
  • Signing an informed consent by the participant or his guardian.

Exclusion Criteria:

  • Prior diagnosis of dementia.
  • Any psychiatric disorder, except for mild depression for at least six months.
  • Shall be excluded those with scores> 12 on the Hamilton scale.
  • History of neurosurgery and implantation of metal clips, head trauma, implantation of cardiac pacemakers, stroke, transient ischemic attack, cardiac surgery
  • Clinical or neurological diseases with an impact on cognitive ability
  • Neurodegenerative central nervous system (eg Parkinson's disease)
  • Alcohol and other drug dependency with abstinence for less than a year
  • Use of psychotropic medications (anticholinergic, mood stabilizers, neuroleptics), except for antidepressants
  • Chronic use of benzodiazepines with abstinence for less than six months
  • Use of vitamin supplements (multivitamins, folic acid, vitamin B12), ginkgo biloba
  • Severe uncontrolled organic disease that could interfere in the conduct of the study, such as cancer, heart disease, digestive disorders, diabetes mellitus type I or type II, uncontrolled dyslipidemia etc.
  • Sensory disabilities, intellectual, preventing them from adequately perform the necessary tests to assess cognitive function
  • Cerebrovascular disease based on Hachinsky score.
  • History of head trauma.
  • Any other condition that in the opinion of the investigator makes problematic the inclusion of the patient in a trial of this nature, as well as patients who do not adhere or not to cooperate.
  • Worsening of the primary symptoms during the treatment.

Sites / Locations

  • University of Sao Paulo General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

rTMS versus Sham

rTMS versus sham

Arm Description

rTMS: active coil Sham: inactive coil

rTMS group: active coil Sham group: inactive coil

Outcomes

Primary Outcome Measures

Repetitive transcranial magnetic stimulation improves memory in elderly with memory complaints
Neuropsychological tests - RBMT (Rivermead Behavioral and Memory Test)

Secondary Outcome Measures

Repetitive transcranial magnetic stimulation improves global cognition of elderly with memory complaints
Performance on neuropsychological tests - STROOP, Trails 1 and 2, mini mental status exam (MMSE), clock drawing test, Wechsler, WAISS III, verbal fluency.

Full Information

First Posted
October 5, 2010
Last Updated
April 20, 2011
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01292382
Brief Title
Effects of rTMS on the Cognition of Elderly With Mild Memory Complaints
Acronym
TMSMemOld
Official Title
Effects of rTMS on the Cognition of Elderly With Cognitive Impairment no Dementia ( CIND )
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Memory is constituted by a set of mental abilities of information processing that will be available at a later time. Flawless performance depends on several brain systems and other cognitive domains. Normal aging is characterized by cognitive deficits that may worsen the production capacity and quality of life. Such deficits represent variations of normal , and may stabilize,or even better progress. Include multiple cognitive domains, such as working and episodic memory, and attention. Despite the heterogeneity of the nature and severity of these deficits, common characteristics were observed in neuropsychological assessment of that population, for example, reduction in processing speed. There is an important gap in the therapeutic approach of these individuals. Transcranial magnetic stimulation (TMS) is a noninvasive and promising intervention, with potential to improve memory and cognition activating networks that operate on memory or other networks that interfere with cognitive performance. The technique relies on generating a variable magnetic field originated from an alternating electric current applied to the human skull reaching focal cortical regions. This study is a sham-controlled clinical trial, randomized, double-blind study. It will be evaluated the effects of repetitive transcranial magnetic stimulation (rTMS) on global cognition (memory, attention, language, executive functions, planning, logical reasoning, calculation and visual-spatial perception), especially memory, of elderly individuals with mild cognitive impairment, included in the domain of cognitive impairment no dementia (CIND).
Detailed Description
Subjects: I. Eligibility criteria: Male and female participants Older adults aged 60-74 years Education ≥ 4 years Performance on neuropsychological tests below normal for age and education Availability to attend the sessions of the application of TMS and neuropsychological assessments Signing an informed consent by the participant or his guardian II. No eligibility criteria: Prior diagnosis of dementia Any psychiatric disorder, except for mild depression in remission for at least 6 months. Shall be excluded those with scores > 12 on the Hamilton Depression Scale History of neurosurgery and implantation of metal clips, head trauma, implantation of cardiac pacemakers, stroke, transient ischemic attack, cardiac surgery Clinical or neurological diseases with impact on cognitive ability Neurodegenerative central nervous system disease(eg. Parkinson Disease) Alcohol and other drug abstinence for less than one year Use of psychotropic medications (anticholinergic, mood stabilizers, neuroleptics), except for antidepressants Chronic use of benzodiazepines with abstinence for less than 6 months Severe uncontrolled organic disease that might interfere with the conduct of the study, such as cancer, congestive heart disease, digestive disorders, diabetes mellitus type I or type II, dyslipidemia etc. Sensory impairments(to guarantee a adequate performance in the tests to evaluate cognitive functions) Magnetic resonance imaging of the brain with evidence of lacunar or large vessels infarctions, cerebral hemorrhage 13. Hachinski Ischemic score of > 7 (or modified by Loeb > 5) 14. Any other condition that in the opinion of the investigator becomes problematic inclusion of the patient in a trial of this nature, as well as patients who do not adhere or do not cooperate. III. Outcome measures: Will be considered as an outcome measure a variation greater than or equal to 10% compared to baseline scores of neuropsychological tests, which will be applied on three occasions: immediately before (T0), after treatment (T2) and 4 weeks after the end of it (T3).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Elderly, Memory, Cognition, Repetitive transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rTMS versus Sham
Arm Type
Sham Comparator
Arm Description
rTMS: active coil Sham: inactive coil
Arm Title
rTMS versus sham
Arm Type
Active Comparator
Arm Description
rTMS group: active coil Sham group: inactive coil
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Other Intervention Name(s)
Active rTMS group, Sham rTMS group
Intervention Description
Intensity: 110% of motor threshold Frequency: 10 Hz Number of trains: 40 trains Duration of trains: 5 seconds Interval: 25 seconds Number of sessions: 10 sessions Duration of intervention: two consecutive weeks
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Other Intervention Name(s)
Arm 1: Active rTMS, Arm 2: Sham rTMS
Intervention Description
Intensity: 110% of motor threshold Frequency: 10 Hz Number of trains: 40 Duration of trains: 5 seconds Interval inter trains: 25 seconds Number of pulses each session: 2.000 Total number of pulses: 20.000
Primary Outcome Measure Information:
Title
Repetitive transcranial magnetic stimulation improves memory in elderly with memory complaints
Description
Neuropsychological tests - RBMT (Rivermead Behavioral and Memory Test)
Time Frame
Neuropsychological tests: T1 - effects after rTMS, and T2: 4 weeks after rTMS
Secondary Outcome Measure Information:
Title
Repetitive transcranial magnetic stimulation improves global cognition of elderly with memory complaints
Description
Performance on neuropsychological tests - STROOP, Trails 1 and 2, mini mental status exam (MMSE), clock drawing test, Wechsler, WAISS III, verbal fluency.
Time Frame
Neuropsychological tests: T1 - effects after rTMS, and T2: 4 weeks after rTMS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants of both sexes Aged between 60 and 74 years Schooling ≥ 4 years Performance on neuropsychological tests of up to 1.5 standard deviations below normal for age and education Signing an informed consent by the participant or his guardian. Exclusion Criteria: Prior diagnosis of dementia. Any psychiatric disorder, except for mild depression for at least six months. Shall be excluded those with scores> 12 on the Hamilton scale. History of neurosurgery and implantation of metal clips, head trauma, implantation of cardiac pacemakers, stroke, transient ischemic attack, cardiac surgery Clinical or neurological diseases with an impact on cognitive ability Neurodegenerative central nervous system (eg Parkinson's disease) Alcohol and other drug dependency with abstinence for less than a year Use of psychotropic medications (anticholinergic, mood stabilizers, neuroleptics), except for antidepressants Chronic use of benzodiazepines with abstinence for less than six months Use of vitamin supplements (multivitamins, folic acid, vitamin B12), ginkgo biloba Severe uncontrolled organic disease that could interfere in the conduct of the study, such as cancer, heart disease, digestive disorders, diabetes mellitus type I or type II, uncontrolled dyslipidemia etc. Sensory disabilities, intellectual, preventing them from adequately perform the necessary tests to assess cognitive function Cerebrovascular disease based on Hachinsky score. History of head trauma. Any other condition that in the opinion of the investigator makes problematic the inclusion of the patient in a trial of this nature, as well as patients who do not adhere or not to cooperate. Worsening of the primary symptoms during the treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hellen Marra
Phone
55 11 3069-8159
Email
hellen.marra@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Marcolin
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
ZIP/Postal Code
05453-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hellen Marra
Phone
+55 11 3069 8159
Email
hellen.marra@usp.br
First Name & Middle Initial & Last Name & Degree
Marco Marcolin
Phone
+55 11 3069 8159
Email
marcolin@usp.br
First Name & Middle Initial & Last Name & Degree
Marco Marcolin

12. IPD Sharing Statement

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Effects of rTMS on the Cognition of Elderly With Mild Memory Complaints

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