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Non-Pharmacological Treatments and Cognitive Impairment (NPT-CI2019)

NCT04118686 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-10-08

No results posted yet for this study

Summary

The prevalence of neurodegenerative diseases is expected to increase over the next years, in parallel with the aging of the world population. Therefore, it is important to identify new methods to prevent, delay or stop the neurodegenerative waterfall responsible for dementia conversion. To date, there is no fully proven pharmacological treatment for cognitive impairment and the available pharmacological armamentariums have limited efficacy because consist in symptomatic drugs with adverse side effects. On this point, non-pharmacological intervention may represent adjunctive therapy to medications in order to prevent or delay the onset of the cognitive deficits or dementia. This study aims to evaluate the effectiveness of a combined treatment protocol associating a Computerized cognitive training (CoRe) with non-invasive brain stimulation techniques: the transcranial Direct Current Stimulation (tDCS) or the repetitive Transcranial Magnetic Stimulation (rTMS). Patients with mild dementia or Mild Cognitive Impairment (MCI) are enrolled and randomly assigned to the experimental group (CoRe + anodic tDCS/rTMS) or control group (CoRe + sham tDCS/ sham rTMS). All patients are evaluated before (T0) and after (T1) treatment with an exhaustive neuropsychological assessment. Furthermore, follow-up visits are scheduled 6 months (T2) and 12 months (T3) after the end of the treatment.

Conditions

Interventions

OTHER

CoRe software training plus non-invasive brain stimulation techniques (anodical tDCS / rTMS)

CT program with Computerized cognitive training (CoRe) plus stimulation that modulates cortical activities by delivering strong magnetic pulses to the cortex through the scalp (rTMS) and weak electrical currents to the scalp to modulate neuronal transmembrane potential towards hyperpolarization or depolarization (tDCS).

OTHER

CoRe software training plus sham non-invasive brain stimulation (sham tDCS/ sham rTMS)

CT program with Computerized cognitive training (CoRe) plus sham stimulation

Sponsors & Collaborators

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    lead OTHER

Principal Investigators

  • Elena Sinforiani, MD · Struttura Semplice Neuropsicologia Clinica/Centro UVA

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-15
Primary Completion
2020-12-15
Completion
2020-12-15

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04118686 on ClinicalTrials.gov