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

Mild Cognitive Impairment Clinical Trial

Official title: Effects of rTMS on the Cognition of Elderly With Cognitive Impairment no Dementia ( CIND )

Status Recruiting

Clinical Trial 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).

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

• NCT number: NCT01292382
• Study type: Interventional
• Source: University of Sao Paulo General Hospital
• Contact: Hellen Marra
• Phone: 55 11 3069-8159
• Email: hellen.marra@usp.br
• Status: Recruiting
• Phase: N/A
• Start date: November 2010
• Completion date: July 2012