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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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