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

Not Applicable

Terminated

• Conditions: Alzheimer Disease (AD)
• Interventions: Device: Sham tDCS; Device: Anodal tDCS

• Registration Number: NCT06619795
• Lead Sponsor: Universita di Verona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2024-09
• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-27
• Study First Posted: 2024-10-01
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CogS	Sham tDCS	The participants underwent cognitive treatment while receiving sham tDCS stimulation.
MotS	Sham tDCS	The participants underwent motor treatment while receiving sham tDCS stimulation
CogA	Anodal tDCS	The participants underwent cognitive treatment while simultaneously receiving anodal stimulation with tDCS.
MotA	Anodal tDCS	The participants underwent motor treatment while simultaneously receiving anodal stimulation with tDCS.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Picture Recognition (PR)	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).
Digit Span Test- Forward (DSF)	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)
Digit Span Test- Backward (DSB)	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).
Phonemic Fluency Test (PFT)	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).
Visual Search Test (VST)	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).
Sustained Attention to Response Test (SART)	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)
Neuropsychiatric Inventory (NPI)	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).

Trial Locations

Locations (1)

Mons. A. Mazzali Foundation; 🇮🇹 Mantova, Italy