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

NCT04118686 | Unknown

• 1 other identifier: NPT-CI2019
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Keywords

Neurodegenerative disease; Cognitive decline; Non-pharmacological treatments; Cognitive training; Non-invasive brain stimulation

Outcome Measures

Primary Outcomes (2)

• Change in global cognitive functioning measured by Mini-Mental State Examination (MMSE)

  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.

  After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program

• Change in global cognitive functioning measured by Montreal Overall Cognitive Assessment (MoCA)

  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.

  After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program

Secondary Outcomes (5)

• Change in memory

  After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program

• Change in executive functions

  After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program

• Change in mood (assessed by Beck Depression Inventory - BDI)

  After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program

• Change in Quality of Life (assessed by Short Form-36 Health Survey - SF - 36)

  After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program

• Change in the evolution of cognitive profile (assessed by Clinical Dementia Rating Scale - CDR)

  After 3 -week intervention program (T1), 6 months (T2) and 1 year (T3) after the end of intervention program

Study Arms (2)

Experimental group

EXPERIMENTAL

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)

Control group

SHAM COMPARATOR

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)

Interventions

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

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).

Experimental group

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

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

Control group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

Struttura Semplice Neuropsicologia Clinica/ Centro UVA

Pavia, 27100, Italy

RECRUITING

Related Publications (9)

• Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available.

  PMID: 28735855 BACKGROUND

• Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.

  PMID: 25405755 BACKGROUND

• Coyle H, Traynor V, Solowij N. Computerized and virtual reality cognitive training for individuals at high risk of cognitive decline: systematic review of the literature. Am J Geriatr Psychiatry. 2015 Apr;23(4):335-359. doi: 10.1016/j.jagp.2014.04.009. Epub 2014 May 14.

  PMID: 24998488 BACKGROUND

• Bernini S, Alloni A, Panzarasa S, Picascia M, Quaglini S, Tassorelli C, Sinforiani E. A computer-based cognitive training in Mild Cognitive Impairment in Parkinson's Disease. NeuroRehabilitation. 2019;44(4):555-567. doi: 10.3233/NRE-192714.

  PMID: 31256092 BACKGROUND

• Prehn K, Floel A. Potentials and limits to enhance cognitive functions in healthy and pathological aging by tDCS. Front Cell Neurosci. 2015 Sep 14;9:355. doi: 10.3389/fncel.2015.00355. eCollection 2015.

  PMID: 26441526 BACKGROUND

• Hsu WY, Ku Y, Zanto TP, Gazzaley A. Effects of noninvasive brain stimulation on cognitive function in healthy aging and Alzheimer's disease: a systematic review and meta-analysis. Neurobiol Aging. 2015 Aug;36(8):2348-59. doi: 10.1016/j.neurobiolaging.2015.04.016. Epub 2015 May 1.

  PMID: 26022770 BACKGROUND

• Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.

  PMID: 21514249 BACKGROUND

• Litvan I, Goldman JG, Troster AI, Schmand BA, Weintraub D, Petersen RC, Mollenhauer B, Adler CH, Marder K, Williams-Gray CH, Aarsland D, Kulisevsky J, Rodriguez-Oroz MC, Burn DJ, Barker RA, Emre M. Diagnostic criteria for mild cognitive impairment in Parkinson's disease: Movement Disorder Society Task Force guidelines. Mov Disord. 2012 Mar;27(3):349-56. doi: 10.1002/mds.24893. Epub 2012 Jan 24.

  PMID: 22275317 BACKGROUND

• Rodella C, Bernini S, Panzarasa S, Sinforiani E, Picascia M, Quaglini S, Cavallini E, Vecchi T, Tassorelli C, Bottiroli S. A double-blind randomized controlled trial combining cognitive training (CoRe) and neurostimulation (tDCS) in the early stages of cognitive impairment. Aging Clin Exp Res. 2022 Jan;34(1):73-83. doi: 10.1007/s40520-021-01912-0. Epub 2021 Jun 22.

  PMID: 34156651 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Neurodegenerative Diseases

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Elena Sinforiani, MD

  Struttura Semplice Neuropsicologia Clinica/Centro UVA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cinzia Fattore, MD

CONTACT

0039 0382 380385; cinzia.fattore@mondino.it

Sara Bottiroli, Ph

CONTACT

0039 0382 380290; sara.bottiroli@mondino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, double-blind, randomized, parallel, controlled study

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 8, 2019
• Study Start: March 15, 2017
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)