Effects of rTMS on the Cognition of Elderly With Mild Memory Complaints
TMSMemOld
1 other identifier
interventional
34
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 9, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedApril 21, 2011
August 1, 2010
Same day
October 5, 2010
April 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Repetitive transcranial magnetic stimulation improves memory in elderly with memory complaints
Neuropsychological tests - RBMT (Rivermead Behavioral and Memory Test)
Neuropsychological tests: T1 - effects after rTMS, and T2: 4 weeks after rTMS
Secondary Outcomes (1)
Repetitive transcranial magnetic stimulation improves global cognition of elderly with memory complaints
Neuropsychological tests: T1 - effects after rTMS, and T2: 4 weeks after rTMS
Study Arms (2)
rTMS versus Sham
SHAM COMPARATORrTMS: active coil Sham: inactive coil
rTMS versus sham
ACTIVE COMPARATORrTMS group: active coil Sham group: inactive coil
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Worsening of the primary symptoms during the treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo General Hospital
São Paulo, São Paulo, 05453-010, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Marcolin
University of Sao Paulo General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 5, 2010
First Posted
February 9, 2011
Study Start
November 1, 2010
Primary Completion
November 1, 2010
Study Completion
July 1, 2012
Last Updated
April 21, 2011
Record last verified: 2010-08