Combined Effect of tDCS and Motor or Cognitive Activity in Patients With Alzheimer's Disease

October 8, 2024 updated by: Valentina Varalta, Universita di Verona

Combined Effect of tDCS and Motor or Cognitive Activity in Patients With Alzheimer's Disease: A Proof-of-Concept Pilot Study

The goal of this clinical trial is to evaluate the effectiveness of combining tDCS with motor or cognitive activities on cognitive functions in patients with AD. Second aim is to investigate if tDCS has a different impact if it is combined with motor or cognitive activities.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Mantova, Italy, 461000
        • Mons. A. Mazzali Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mini Mental State Examination (MMSE) major or equal to 15;
  • good level of compliance;
  • acetylcholinesterase inhibitor treatment (e.g., donepezil, rivastigmine);
  • no modifications of medication during the last four months.

Exclusion Criteria:

  • behavioral disorders (e.g., aggressiveness);
  • alcohol abuse;
  • orthopedic pathology with risk of falls to the ground;
  • respiratory pathology;
  • severe auditory or visual deficits uncorrected;
  • history of epileptic fits;
  • anti-epileptic medication;
  • metallic body implants; pacemaker;
  • psychiatric, neurologic, systemic or metabolic disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: CogS
The participants underwent cognitive treatment while receiving sham tDCS stimulation.
Device: Sham tDCS
In addition to Sham tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group.
Sham Comparator: MotS
The participants underwent motor treatment while receiving sham tDCS stimulation
Device: Sham tDCS
In addition to Sham tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group.
Experimental: CogA
The participants underwent cognitive treatment while simultaneously receiving anodal stimulation with tDCS.
Device: Anodal tDCS
In addition to anodal tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group.
Experimental: MotA
The participants underwent motor treatment while simultaneously receiving anodal stimulation with tDCS.
Device: Anodal tDCS
In addition to anodal tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Mental State Examination (MMSE)
Time Frame: From enrollment to the end of treatment at two weeks
(Range: 0-30; higher score=best performance).
From enrollment to the end of treatment at two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Picture Recognition (PR)
Time Frame: From enrollment to the end of treatment at two weeks
Picture Recognition (PR) is a subtest of the Rivermead Behavioral Memory Test-3, an ecological memory battery resembling everyday tasks, with the aim to measure daily memory function. The examinee is shown a set of picture and then is asked to recognize them from a further set of pictures at a later time in the testing session. It has two parallel version for monitoring changes over time (Range: 0-15; higher score=best performance).
From enrollment to the end of treatment at two weeks
Digit Span Test- Forward (DSF)
Time Frame: From enrollment to the end of treatment at two weeks
Digit Span Test- Forward (DSF), used to measure span of immediate verbal recall. The examiner presents digits verbally at a rate of one per second. Examiner requires the participant to repeat the digits in the same order. The number of digits increases by one until the participant consecutively fails two trials of the same digit span length (higher score=best performance)
From enrollment to the end of treatment at two weeks
Digit Span Test- Backward (DSB)
Time Frame: From enrollment to the end of treatment at two weeks
Digit Span Test- Backward (DSB), used to measure working memory. The examiner presents digits verbally and repeats the digits in reverse order. The number of digits increases by one until the participant consecutively fails two trials of the same digit span length (higher score=best performance).
From enrollment to the end of treatment at two weeks
Phonemic Fluency Test (PFT)
Time Frame: From enrollment to the end of treatment at two weeks
Phonemic Fluency Test (PFT), used to measure processing speed, language production and executive functions. Participants are given one minute to produce as many unique words as possible starting with a given letter. The participant's score in each task is given by the number of correct words (higher score=best performance).
From enrollment to the end of treatment at two weeks
Visual Search Test (VST)
Time Frame: From enrollment to the end of treatment at two weeks
Visual Search Test (VST), to assess visual-selective attention. Three matrices are shown to the subject and the patients has to cross in 45 minutes the target stimuli between distractors (Range: 0-60; higher score=best performance).
From enrollment to the end of treatment at two weeks
Sustained Attention to Response Test (SART)
Time Frame: From enrollment to the end of treatment at two weeks
Sustained Attention to Response Test (SART): used to evaluate sustained attention and control inhibition. In the test, participants view a computer monitor on which a random series of single digits are presented at the regular rate of 1 per 1.15 seconds. The task is to press a single response key following each presentation with the exception of a nominated no-go digit, to which no response should be made. In the standard version of the test, 225 digits are presented in a continuous sequence over 4.3 minutes. The outcomes are false allarm (FA), omission (OM) and reaction times (RT) (higher score = worst performance)
From enrollment to the end of treatment at two weeks
Neuropsychiatric Inventory (NPI)
Time Frame: From enrollment to the end of treatment at two weeks
Neuropsychiatric Inventory (NPI) to evaluate the presence, frequency and severity of behavioral disorders (Range 0-144; higher score = worst performance).
From enrollment to the end of treatment at two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140158

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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