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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04118686
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
IRCCS National Neurological Institute "C. Mondino" Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Other: CoRe software training plus non-invasive brain stimulation techniques (anodical tDCS / rTMS) Other: CoRe software training plus sham non-invasive brain stimulation (sham tDCS/ sham rTMS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, double-blind, randomized, parallel, controlled study
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: New Approaches for the Treatment of Early Stages of Cognitive Impairment in Neurodegenerative Diseases
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
The group receives CoRe software training plus non-invasive brain stimulation techniques (anodical tDCS / rTMS)
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).

Sham Comparator: Control group
The group receives CoRe software training plus sham non-invasive brain stimulation (sham tDCS/ sham rTMS)
Other: CoRe software training plus sham non-invasive brain stimulation (sham tDCS/ sham rTMS)
CT program with Computerized cognitive training (CoRe) plus sham stimulation




Primary Outcome Measures :
  1. Change in global cognitive functioning measured by Mini-Mental State Examination (MMSE) [ Time Frame: After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program ]
    It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. The score is between 0-30. Lower score is worse cognitive functioning.

  2. Change in global cognitive functioning measured by Montreal Overall Cognitive Assessment (MoCA) [ Time Frame: After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program ]

    It is a widely used screening assessment for detecting cognitive impairment. It assesses several cognitive domains:

    The short-term memory recall task (5 points). Visuospatial abilities a clock-drawing task (3 points) and a three-dimensional cube copy (1 point). Multiple aspects of executive functions are assessed using an alternation task adapted from the trail-making B task (1 point), a phonemic fluency task (1 point), and a two-item verbal abstraction task (2 points). Attention, concentration, and working memory are evaluated using a three-item confrontation naming task with low-familiarity animals (3 points), repetition of two syntactically complex sentences (2 points), and the aforementioned fluency task. Finally, orientation to time and place (6 points). Low score is worse outcome.



Secondary Outcome Measures :
  1. Change in memory [ Time Frame: After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program ]
    Verbal and spatial span; verbal long-ter memory; spatial long-term memory by using scales. Higher scores are better outcomes.

  2. Change in executive functions [ Time Frame: After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program ]
    Logical-executive functions; attention; visuospatial abilities by using scale. Higher scorea are better outcomes.

  3. Change in mood (assessed by Beck Depression Inventory - BDI) [ Time Frame: After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program ]
    Contains 21 questions. The items are rated on a 4-point severity scale (0-3) and are summed to give a total score (range 0-63). A higher score denotes more severe depression.

  4. Change in Quality of Life (assessed by Short Form-36 Health Survey - SF - 36) [ Time Frame: After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program ]
    Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carriers equal weight. Low score is worse quality of life.

  5. Change in the evolution of cognitive profile (assessed by Clinical Dementia Rating Scale - CDR) [ Time Frame: After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program ]
    CDR is a widely utilized clinical tool for grading the relative severity of dementia with scores that range from 0 (no impairment) to 3 (severe impairment)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of mild dementia or mild cognitive impairment;
  • age between 50 and 85 years;
  • educational level ≥ 5 years.

Exclusion Criteria:

  • pre-existing cognitive impairment (e.g. aphasia, neglect);
  • severe disturbances in consciousness;
  • concomitant severe psychiatric disease or others neurological conditions (e.g. depression and behavioural disorders).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118686


Contacts
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Contact: Cinzia Fattore, MD 0039 0382 380385 cinzia.fattore@mondino.it
Contact: Sara Bottiroli, Ph 0039 0382 380290 sara.bottiroli@mondino.it

Locations
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Italy
Struttura Semplice Neuropsicologia Clinica/ Centro UVA Recruiting
Pavia, Italy, 27100
Contact: Elena Sinforiani, MD    0039 0382 380290    elena.sinforiani@mondino.it   
Contact: sara bernini bernini, PhD    0039 0382 380290    sara.bernini@mondino.it   
Sponsors and Collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation
Investigators
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Principal Investigator: Elena Sinforiani, MD Struttura Semplice Neuropsicologia Clinica/Centro UVA
Publications:

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Responsible Party: IRCCS National Neurological Institute "C. Mondino" Foundation
ClinicalTrials.gov Identifier: NCT04118686    
Other Study ID Numbers: NPT-CI2019
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRCCS National Neurological Institute "C. Mondino" Foundation:
Neurodegenerative disease
Cognitive decline
Non-pharmacological treatments
Cognitive training
Non-invasive brain stimulation
Additional relevant MeSH terms:
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Neurodegenerative Diseases
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Nervous System Diseases