Primary Progressive AphasiaACROSSNCT04187391
The Effects of a Multimodal Approach for the Treatment of PPA
A study testing Active tDCS, Language training and Unstructured cognitive training in people with Primary Progressive Aphasia, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial summary
Primary Progressive Aphasia (PPA) is an untreatable neurodegenerative disorder that disrupts language functions. Available therapies are mainly symptomatic and recently attention has been gained by new techniques that allow for noninvasive brain stimulation such as transcranial direct current stimulation (tDCS). Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Primary Progressive Aphasia
- What is being tested?
- Active tDCS, Language training and Unstructured cognitive training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2020to 31 Mar 2024
- 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 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis avPPA according to the current clinical criteria (Gorno-Tempini et al., 2011)
- FTD Clinical Dementia Rating (FTD-CDR) score >0.5 and <2
Who cannot join
- Presence of any medical or psychiatric illness that could interfere in completing assessments
- Presence of any medical condition that represents a contraindication to tDCS.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, BS, 25125
About this study
Official title: The Effects of a Multimodal Approach for the Treatment of Primary Progressive Aphasia
Primary Progressive Aphasia (PPA) is an untreatable neurodegenerative disorder that disrupts language functions. Available therapies are mainly symptomatic and recently attention has been gained by new techniques that allow for noninvasive brain stimulation such as transcranial direct current stimulation (tDCS). The primary objective of this study is to evaluate whether the application of Active tDCS (anode over the left dorsolateral prefrontal cortex- DLPFC with the cathode over the right supraorbital region) to the scalp during individualized language training, would improve naming abilities in the agrammatic variant of PPA (avPPA) more than use of one methodology alone. The effect of treatment on the clinical symptoms will be related to changes in brain activity (Magnetic Resonance Imaging, MRI and Functional near-infrared spectroscopy fNIRS) and in biological markers, using a multimodal approach. Finally, we will assess the long-term effects of this approach.
Read the detailed description
45 patients with avPPA, will be recruited from IRCCS Istituto Centro San Giovanni di Dio Brescia, Italy and ASST Spedali Civili Brescia, Italy .
Inclusion criteria will be a diagnosis avPPA according to the current clinical criteria (Gorno-Tempini et al., 2011) and a FTD Clinical Dementia Rating score >0.5 and <2. Exclusion criteria will be the presence of any medical or psychiatric illness that could interfere in completing assessments and the presence of any medical condition that represents a contraindication to tDCS. All the patients will undergo five consecutive days a week for two weeks of treatment sessions:
15 patients will receive Active tDCS over DLPFC while performing a language training; 15 patients will receive placebo tDCS during language training; 15 patients will receive Active tDCS over DLPFC during unstructured cognitive training.
Two trained neuropsychologists will administer the neuropsychological testing in two sessions. At baseline (T0), post-treatment (T1) and 3-months (T2) follow-up assessments were conducted by the same assessor. Blood sample withdrawal at baseline (T0) and after the DLPFC-tDCS intervention (T1) will be assessed.
To elucidate the mechanisms underlying tDCS effects, structural imaging, functional connectivity (fMRI) alterations and concentration changes of hemoglobin (fNIRS) will be collected off-line. Each avPPA patient will undergo an MRI scan at the ASST Spedali Civili Brescia, Italy at T0 and T1 and a fNIRS acquisition at the IRCCS Istituto Centro San Giovanni di Dio Brescia, Italy at T0, T1 and T2.
- Conditions
- Primary Progressive Aphasia
- Being tested
- Active tDCS, Placebo tDCS, Language training, Unstructured cognitive training
- Medical subject headings
- Aphasia, Primary Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Active tDCS anode is applied over the left DLPFC with the cathode over the right supraorbital region.
Placebo tDCSDevice
Placebo tDCS is applied but the current is turned off 10 seconds after the beginning and turned on for the last 10 seconds of the stimulation period.
Language trainingBehavioural
patients receive language training
Unstructured cognitive trainingBehavioural
patients receive unstructured cognitive training.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS plus individual language training | Experimental | Active tDCS plus individual language training Receives: Device: Active tDCS; Behavioral: Language training |
| placebo tDCS plus individual language training | Active comparator | placebo tDCS plus individual language training Receives: Device: Placebo tDCS; Behavioral: Language training |
| Active tDCS plus unstructured cognitive stimulation | Active comparator | Active tDCS plus unstructured cognitive stimulation Receives: Device: Active tDCS; Behavioral: Unstructured cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in naming test scores on Picture Naming Task
Picture Naming Task: percentage of correct responses (0-100)
Measured: Baseline up to 2 weeks and 3 months
Secondary outcomes (13)
Change in quality of life on Stroke and Aphasia Quality of Life
Stroke and Aphasia Quality of Life (0-5; higher scores=better quality of life)
Measured: Baseline up to 2 weeks and 3 months
Change in dementia severity on Frontotemporal Dementia-modified Clinical Dementia Rating Scale
Frontotemporal Dementia-modified Clinical Dementia Rating Scale (0-3; higher scores=greater dementia severity)
Measured: Baseline up to 2 weeks and 3 months
Change in cognitive impairment on Mini Mental State Examination
Mini Mental State Examination (0-30; higher scores=better cognitive abilities)
Measured: Baseline up to 2 weeks and 3 months
Change in verbal long term memory on Story Recall
Story Recall (0-28; higher scores=better memory abilities)
Measured: Baseline up to 2 weeks and 3 months
Change in nonverbal long term memory on Rey-Osterrieth Complex Figure-Recall
Rey-Osterrieth Complex Figure-Recall (0-36; higher scores=better abilities)
Measured: Baseline up to 2 weeks and 3 months
Change in attentional abilities on Trial Making Test
Trial Making Test (milliseconds; higher scores=worse abilities)
Measured: Baseline up to 2 weeks and 3 months
Change in constructional praxia on Rey-Osterrieth Complex Figure-Copy
Rey-Osterrieth Complex Figure-Copy (0-36; higher scores=better abilities)
Measured: Baseline up to 2 weeks and 3 months
Change in fluency abilities on Verbal Fluency (semantic and phonemic)
Verbal Fluency (semantic and phonemic) Test (higher scores=better abilities)
Measured: Baseline up to 2 weeks and 3 months
Change in aphasia severity on Screening for Neurodegenerative Aphasia
Screening for Neurodegenerative Aphasia Battery (higher scores=better abilities)
Measured: Baseline up to 2 weeks and 3 months
Change in naming on naming subtest from Aachener Aphasie Test
naming subtest from Aachener Aphasie Test (0-120; higher scores=better abilities)
Measured: Baseline up to 2 weeks and 3 months
Change in language impairment on Mini Language State Examination
Mini Language State Examination Battery (higher scores=better abilities)
Measured: Baseline up to 2 weeks and 3 months
Change in molecular biomarkers on neurogranin
neurogranin
Measured: Baseline up to 2 weeks
Change in imaging biomarkers on fMRI and fNIRS
fMRI and fNIRS
Measured: Baseline up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start15 Jan 2020
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Progressive AphasiaStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- Asst Degli Spedali Civili Di Brescia
- Responsible party
- Sponsor
- Investigators
- Rosa Manenti, PhD, Principal investigator, IRCCS Istituto Centro San Giovanni di Dio- Fatebenefratelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187391
- Sponsor's protocol ID
- GR 2018 12365105
- Acronym
- ACROSS
- Status last verified
- Oct 2024
- First submitted
- 29 Nov 2019
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Multimodal Approach for the Treatment of Primary Progressive Aphasia
- ClinicalTrials.gov ID
- NCT04187391
- Acronym / sponsor ID
- ACROSS / GR 2018 12365105
- Conditions
- Primary Progressive Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Collaborators
- Asst Degli Spedali Civili Di Brescia
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 5 Dec 2019 (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.
Primary Progressive Aphasia (PPA) is an untreatable neurodegenerative disorder that disrupts language functions. Available therapies are mainly symptomatic and recently attention has been gained by new techniques that allow for noninvasive brain stimulation such as transcranial direct current stimulation (tDCS). The primary objective of this study is to evaluate whether the application of Active tDCS (anode over the left dorsolateral prefrontal cortex- DLPFC with the cathode over the right supraorbital region) to the scalp during individualized language training, would improve naming abilities in the agrammatic variant of PPA (avPPA) more than use of one methodology alone. The effect of treatment on the clinical symptoms will be related to changes in brain activity (Magnetic Resonance Imaging, MRI and Functional near-infrared spectroscopy fNIRS) and in biological markers, using a multimodal approach. Finally, we will assess the long-term effects of this approach.
Detailed description
45 patients with avPPA, will be recruited from IRCCS Istituto Centro San Giovanni di Dio Brescia, Italy and ASST Spedali Civili Brescia, Italy .
Inclusion criteria will be a diagnosis avPPA according to the current clinical criteria (Gorno-Tempini et al., 2011) and a FTD Clinical Dementia Rating score >0.5 and <2. Exclusion criteria will be the presence of any medical or psychiatric illness that could interfere in completing assessments and the presence of any medical condition that represents a contraindication to tDCS. All the patients will undergo five consecutive days a week for two weeks of treatment sessions:
15 patients will receive Active tDCS over DLPFC while performing a language training; 15 patients will receive placebo tDCS during language training; 15 patients will receive Active tDCS over DLPFC during unstructured cognitive training.
Two trained neuropsychologists will administer the neuropsychological testing in two sessions. At baseline (T0), post-treatment (T1) and 3-months (T2) follow-up assessments were conducted by the same assessor. Blood sample withdrawal at baseline (T0) and after the DLPFC-tDCS intervention (T1) will be assessed.
To elucidate the mechanisms underlying tDCS effects, structural imaging, functional connectivity (fMRI) alterations and concentration changes of hemoglobin (fNIRS) will be collected off-line. Each avPPA patient will undergo an MRI scan at the ASST Spedali Civili Brescia, Italy at T0 and T1 and a fNIRS acquisition at the IRCCS Istituto Centro San Giovanni di Dio Brescia, Italy at T0, T1 and T2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active tDCS plus individual language training | Experimental | Device: Active tDCS, Behavioral: Language trainingActive tDCS plus individual language training |
| placebo tDCS plus individual language training | Active comparator | Device: Placebo tDCS, Behavioral: Language trainingplacebo tDCS plus individual language training |
| Active tDCS plus unstructured cognitive stimulation | Active comparator | Device: Active tDCS, Behavioral: Unstructured cognitive trainingActive tDCS plus unstructured cognitive stimulation |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis avPPA according to the current clinical criteria (Gorno-Tempini et al., 2011)
- FTD Clinical Dementia Rating (FTD-CDR) score >0.5 and <2
Key exclusion criteria (2 listed)
- Presence of any medical or psychiatric illness that could interfere in completing assessments
- Presence of any medical condition that represents a contraindication to tDCS.
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 |
|---|---|---|
| Active tDCSActive tDCS anode is applied over the left DLPFC with the cathode over the right supraorbital region. | Device | Active tDCS plus individual language training, Active tDCS plus unstructured cognitive stimulation |
| Placebo tDCSPlacebo tDCS is applied but the current is turned off 10 seconds after the beginning and turned on for the last 10 seconds of the stimulation period. | Device | placebo tDCS plus individual language training |
| Language trainingpatients receive language training | Behavioural | Active tDCS plus individual language training, placebo tDCS plus individual language training |
| Unstructured cognitive trainingpatients receive unstructured cognitive training. | Behavioural | Active tDCS plus unstructured cognitive stimulation |
Primary outcome
Change in naming test scores on Picture Naming Task
Time frame: Baseline up to 2 weeks and 3 months
Picture Naming Task: percentage of correct responses (0-100)
13 secondary outcomes
Change in quality of life on Stroke and Aphasia Quality of Life
Time frame: Baseline up to 2 weeks and 3 months
Change in dementia severity on Frontotemporal Dementia-modified Clinical Dementia Rating Scale
Time frame: Baseline up to 2 weeks and 3 months
Change in cognitive impairment on Mini Mental State Examination
Time frame: Baseline up to 2 weeks and 3 months
Change in verbal long term memory on Story Recall
Time frame: Baseline up to 2 weeks and 3 months
Change in nonverbal long term memory on Rey-Osterrieth Complex Figure-Recall
Time frame: Baseline up to 2 weeks and 3 months
Change in attentional abilities on Trial Making Test
Time frame: Baseline up to 2 weeks and 3 months
Change in constructional praxia on Rey-Osterrieth Complex Figure-Copy
Time frame: Baseline up to 2 weeks and 3 months
Change in fluency abilities on Verbal Fluency (semantic and phonemic)
Time frame: Baseline up to 2 weeks and 3 months
Change in aphasia severity on Screening for Neurodegenerative Aphasia
Time frame: Baseline up to 2 weeks and 3 months
Change in naming on naming subtest from Aachener Aphasie Test
Time frame: Baseline up to 2 weeks and 3 months
Change in language impairment on Mini Language State Examination
Time frame: Baseline up to 2 weeks and 3 months
Change in molecular biomarkers on neurogranin
Time frame: Baseline up to 2 weeks
Change in imaging biomarkers on fMRI and fNIRS
Time frame: Baseline up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Rosa Manenti, PhD principal investigator
IRCCS Istituto Centro San Giovanni di Dio- Fatebenefratelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS, Language training and Unstructured cognitive training in people with Primary Progressive Aphasia, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 3 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in naming test scores on Picture Naming Task (time frame: Baseline up to 2 weeks and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024.