NCT06619795TerminatedNot Applicable
Combined Effect of tDCS and Motor or Cognitive Activity in Patients With Alzheimer's Disease: A Proof-of-Concept Pilot Study
Universita di Verona2 sites in 1 country23 target enrollmentStarted: June 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Mini Mental State Examination (MMSE)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Mini Mental State Examination (MMSE)
Time Frame: From enrollment to the end of treatment at two weeks
(Range: 0-30; higher score=best performance).
Secondary Outcomes
- 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)
- Sustained Attention to Response Test (SART)(From enrollment to the end of treatment at two weeks)
- Neuropsychiatric Inventory (NPI)(From enrollment to the end of treatment at two weeks)
Investigators
Valentina Varalta
Doctor
Universita di Verona
Study Sites (2)
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