Alzheimer Disease (AD)NCT06619795
Combined Effect of tDCS and Motor or Cognitive Activity in Patients With Alzheimer's Disease
A study testing Anodal tDCS in people with Alzheimer Disease (AD), run by Universita di Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease (AD)
- What is being tested?
- Anodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- anti-epileptic medication;
- metallic body implants; pacemaker;
- psychiatric, neurologic, systemic or metabolic disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alzheimer Disease (AD)
- Being tested
- Anodal tDCS, Sham tDCS
- Keywords
- Transcranial Direct Current Stimulation, Motor Activity, Cognitive Stimulation, Alzheimer's disease
- Medical subject headings
- Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
In addition to anodal tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group.
Sham tDCSDevice
In addition to Sham tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group.
| Study group | Role | What they receive |
|---|---|---|
| CogS | Sham comparator | The participants underwent cognitive treatment while receiving sham tDCS stimulation. Receives: Device: Sham tDCS |
| MotS | Sham comparator | The participants underwent motor treatment while receiving sham tDCS stimulation Receives: Device: Sham tDCS |
| CogA | Experimental | The participants underwent cognitive treatment while simultaneously receiving anodal stimulation with tDCS. Receives: Device: Anodal tDCS |
| MotA | Experimental | The participants underwent motor treatment while simultaneously receiving anodal stimulation with tDCS. Receives: Device: Anodal tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Examination (MMSE)
(Range: 0-30; higher score=best performance).
Measured: From enrollment to the end of treatment at two weeks
Secondary outcomes (7)
Picture Recognition (PR)
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).
Measured: From enrollment to the end of treatment at two weeks
Digit Span Test- Forward (DSF)
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)
Measured: From enrollment to the end of treatment at two weeks
Digit Span Test- Backward (DSB)
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).
Measured: From enrollment to the end of treatment at two weeks
Phonemic Fluency Test (PFT)
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).
Measured: From enrollment to the end of treatment at two weeks
Visual Search Test (VST)
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).
Measured: From enrollment to the end of treatment at two weeks
Sustained Attention to Response Test (SART)
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)
Measured: From enrollment to the end of treatment at two weeks
Neuropsychiatric Inventory (NPI)
Neuropsychiatric Inventory (NPI) to evaluate the presence, frequency and severity of behavioral disorders (Range 0-144; higher score = worst performance).
Measured: From enrollment to the end of treatment at two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Jun 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: The study was interrupted before reaching the planned sample size due to the SARS-CoV-2 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Varalta, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619795
- Sponsor's protocol ID
- 140158
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39595863
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of tDCS and Motor or Cognitive Activity in Patients With Alzheimer's Disease: A Proof-of-Concept Pilot Study
- ClinicalTrials.gov ID
- NCT06619795
- Acronym / sponsor ID
- 140158
- Conditions
- Alzheimer Disease (AD)
- Keywords
- Transcranial Direct Current Stimulation, Motor Activity, Cognitive Stimulation, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was interrupted before reaching the planned sample size due to the SARS-CoV-2 pandemic.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CogS | Sham comparator | Device: Sham tDCSThe participants underwent cognitive treatment while receiving sham tDCS stimulation. |
| MotS | Sham comparator | Device: Sham tDCSThe participants underwent motor treatment while receiving sham tDCS stimulation |
| CogA | Experimental | Device: Anodal tDCSThe participants underwent cognitive treatment while simultaneously receiving anodal stimulation with tDCS. |
| MotA | Experimental | Device: Anodal tDCSThe participants underwent motor treatment while simultaneously receiving anodal stimulation with tDCS. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- behavioral disorders (e.g., aggressiveness);
- alcohol abuse;
- orthopedic pathology with risk of falls to the ground;
- respiratory pathology;
- severe auditory or visual deficits uncorrected;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal tDCSIn addition to anodal tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group. | Device | CogA, MotA |
| Sham tDCSIn addition to Sham tDCS stimulation, participants simultaneously underwent motor or cognitive therapy, depending on their assigned group. | Device | CogS, MotS |
Primary outcome
Mini Mental State Examination (MMSE)
Time frame: From enrollment to the end of treatment at two weeks
(Range: 0-30; higher score=best performance).
7 secondary outcomes
Picture Recognition (PR)
Time frame: 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- Backward (DSB)
Time frame: 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
Visual Search Test (VST)
Time frame: 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
Neuropsychiatric Inventory (NPI)
Time frame: From enrollment to the end of treatment at two weeks
Results and safety
The study was stopped early (reason given: The study was interrupted before reaching the planned sample size due to the SARS-CoV-2 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 39595863Fonte 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS in people with Alzheimer Disease (AD), run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was interrupted before reaching the planned sample size due to the SARS-CoV-2 pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental State Examination (MMSE) (time frame: From enrollment to the end of treatment at two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06619795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.