NCT06619795

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Last Updated

October 15, 2024

Status Verified

September 1, 2024

Enrollment Period

1.6 years

First QC Date

September 17, 2024

Last Update Submit

October 8, 2024

Conditions

Alzheimer Disease (AD)

Keywords

Transcranial Direct Current StimulationMotor ActivityCognitive StimulationAlzheimer's disease

Outcome Measures

Primary Outcomes (1)

  • Mini Mental State Examination (MMSE)

    (Range: 0-30; higher score=best performance).

    From enrollment to the end of treatment at two weeks

Secondary Outcomes (7)

  • Picture Recognition (PR)

    From enrollment to the end of treatment at two weeks

  • Digit Span Test- Forward (DSF)

    From enrollment to the end of treatment at two weeks

  • Digit Span Test- Backward (DSB)

    From enrollment to the end of treatment at two weeks

  • Phonemic Fluency Test (PFT)

    From enrollment to the end of treatment at two weeks

  • Visual Search Test (VST)

    From enrollment to the end of treatment at two weeks

  • +2 more secondary outcomes

Study Arms (4)

CogS

SHAM COMPARATOR

The participants underwent cognitive treatment while receiving sham tDCS stimulation.

Device: Sham tDCS

MotS

SHAM COMPARATOR

The participants underwent motor treatment while receiving sham tDCS stimulation

Device: Sham tDCS

CogA

EXPERIMENTAL

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

Device: Anodal tDCS

MotA

EXPERIMENTAL

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

Device: Anodal tDCS

Interventions

Anodal tDCSDEVICE

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

CogAMotA
Sham tDCSDEVICE

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

CogSMotS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mons. A. Mazzali Foundation

Mantova, 461000, Italy

Location

Related Publications (1)

  • 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.

    PMID: 39595863DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseMotor Activity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 17, 2024

First Posted

October 1, 2024

Study Start

June 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

October 15, 2024

Record last verified: 2024-09

Locations

IT(1)