Mild Cognitive Impairment Clinical Trial
— TMSMemOldOfficial title:
Effects of rTMS on the Cognition of Elderly With Cognitive Impairment no Dementia ( CIND )
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).
Status | Recruiting |
Enrollment | 34 |
Est. completion date | July 2012 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years to 74 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | University of Sao Paulo General Hospital | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | 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. | Neuropsychological tests: T1 - effects after rTMS, and T2: 4 weeks after rTMS | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04513106 -
Promoting Advance Care Planning for Persons With Early-stage Dementia in the Community: a Feasibility Trial
|
N/A | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
Active, not recruiting |
NCT03167840 -
Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment
|
N/A | |
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Not yet recruiting |
NCT05041790 -
A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment
|
Phase 4 | |
Recruiting |
NCT04121156 -
High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment
|
N/A | |
Recruiting |
NCT03605381 -
MORbidity PRevalence Estimate In StrokE
|
||
Completed |
NCT02774083 -
Cognitive Training Using Feuerstein Instrumental Enrichment
|
N/A | |
Completed |
NCT01315639 -
New Biomarker for Alzheimer's Disease Diagnostic
|
N/A | |
Enrolling by invitation |
NCT06023446 -
Can (Optical Coherence Tomography) Pictures of the Retina Detect Alzheimer's Disease at Its Earliest Stages?
|
||
Completed |
NCT04567745 -
Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers
|
Phase 1 | |
Recruiting |
NCT05579236 -
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT03583879 -
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
|
N/A | |
Terminated |
NCT02503501 -
Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease
|
Phase 2 | |
Not yet recruiting |
NCT03740178 -
Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)
|
Phase 1 | |
Active, not recruiting |
NCT05204940 -
Longitudinal Observational Biomarker Study
|
||
Recruiting |
NCT02663531 -
Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease
|
N/A | |
Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
Recruiting |
NCT03507192 -
Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.
|
N/A |