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

NCT ID: NCT06619795

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease (AD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CogS

The participants underwent cognitive treatment while receiving sham tDCS stimulation.

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

In addition to Sham tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group.

MotS

The participants underwent motor treatment while receiving sham tDCS stimulation

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

In addition to Sham tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group.

CogA

The participants underwent cognitive treatment while simultaneously receiving anodal stimulation with tDCS.

Group Type EXPERIMENTAL

Anodal tDCS

Intervention Type DEVICE

In addition to anodal tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group.

MotA

The participants underwent motor treatment while simultaneously receiving anodal stimulation with tDCS.

Group Type EXPERIMENTAL

Anodal tDCS

Intervention Type DEVICE

In addition to anodal tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anodal tDCS

In addition to anodal tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group.

Intervention Type DEVICE

Sham tDCS

In addition to Sham tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Valentina Varalta

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mons. A. Mazzali Foundation

Mantova, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

Fonte C, Rotundo G, Varalta V, Filosa A, Muti E, Barletta C, Evangelista E, Venturelli M, Picelli A, Smania N. Combined Effect of tDCS and Motor or Cognitive Activity in Patients with Alzheimer's Disease: A Proof-of-Concept Pilot Study. Brain Sci. 2024 Oct 30;14(11):1099. doi: 10.3390/brainsci14111099.

Reference Type DERIVED
PMID: 39595863 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

140158

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.