Clinical trial NCT01292382: Effects of rTMS on the Cognition of Elderly With Mild Memory Complaints
Official title: Effects of rTMS on the Cognition of Elderly With Cognitive Impairment no Dementia ( CIND )
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Elderly
Memory
Cognition
Repetitive transcranial magnetic stimulation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2011-02-09
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. Male and female participants
2. Older adults aged 60-74 years
3. Education ≥ 4 years
4. Performance on neuropsychological tests below normal for age and education
5. Availability to attend the sessions of the application of TMS and neuropsychological assessments
6. Signing an informed consent by the participant or his guardian

II. No eligibility criteria:

1. Prior diagnosis of dementia
2. 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
3. History of neurosurgery and implantation of metal clips, head trauma, implantation of cardiac pacemakers, stroke, transient ischemic attack, cardiac surgery
4. Clinical or neurological diseases with impact on cognitive ability
5. Neurodegenerative central nervous system disease(eg. Parkinson Disease)
6. Alcohol and other drug abstinence for less than one year
7. Use of psychotropic medications (anticholinergic, mood stabilizers, neuroleptics), except for antidepressants
8. Chronic use of benzodiazepines with abstinence for less than 6 months
9. 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.
10. Sensory impairments(to guarantee a adequate performance in the tests to evaluate cognitive functions)
11. 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).

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.

Primary outcomes:
measure: Repetitive transcranial magnetic stimulation improves memory in elderly with memory complaints
timeFrame: Neuropsychological tests: T1 - effects after rTMS, and T2: 4 weeks after rTMS
Secondary outcomes:
measure: Repetitive transcranial magnetic stimulation improves global cognition of elderly with memory complaints
timeFrame: Neuropsychological tests: T1 - effects after rTMS, and T2: 4 weeks after rTMS
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Marco Marcolin
role: PRINCIPAL_INVESTIGATOR
References: