Aphasia, Primary ProgressiveStim-APHANCT06473714
Effects of Transcranial Direct Current Stimulation (tDCS) on Inhibition and Brain Function in Primary Progressive Aphasia
A study testing tDCS in people with Aphasia, Primary Progressive, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Primary progressive aphasia (PPA) is a focal dementia characterized by primary impairment of language abilities and functional disturbances associated with language. Although PPA is a progressive disorder, new techniques are being proposed to try to activate parts of the brain previously thought to be potentially… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia, Primary Progressive
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a male or female over the age of 18 with a primary progressive aphasia diagnosis
- Available for treatment and testing sessions
- able to read and speak French
- Be right-handed
Who cannot join
- Presence of neurodevelopmental disorders or non-degenerative neurological disorders
- Post-stroke aphasia
- Language or cognitive disorders too severe to allow task performance or communication
- Pre-existing psychiatric disorders; severe depression, schizophrenia
- People with pacemakers or metal implants, epilepsy
- Presence of a medical condition that represents a contraindication to tDCS
Show all 10Show fewer
- Active use of psychotropic drugs
- Treatment with tDCS or TMS in the last 3 months
- Additional language therapy
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Auriane Gros, Pr contact
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice
Justine LEMAIRE, +33492034778
About this study
Primary progressive aphasia (PPA) is a focal dementia characterized by primary impairment of language abilities and functional disturbances associated with language.
Although PPA is a progressive disorder, new techniques are being proposed to try to activate parts of the brain previously thought to be potentially inactive, due to the possibility of "neuroplasticity". This concept refers to our brain's modularity and learning potential. Transcranial direct current stimulation is a powerful neuromodulatory technique, in which a small current is applied to the participant's scalp through the targeted positioning of an anode and a cathode. The positive or anodal stimulation of tDCS is supposed to increase neuronal activity under the electrode, while cathodal stimulation is supposed to do the opposite.
This project will provide new insights into the nature of the neural activity underlying executive functions in people with primary progressive aphasia compared to those without. The investigators expect to find reduced amplitude of electrophysiological responses and lower accuracy in people with primary progressive aphasia compared with healthy controls. Given the results of previous studies showing the efficacy of tDCS protocols in the treatment of aphasia, the investigators might expect them to improve executive functions. If so, the investigators expect significantly greater electrophysiological responses after stimulation sessions compared with sham conditions. This project is of great clinical relevance. This research will improve current therapeutic protocols used in the treatment of PPA by providing critical findings on whether and how the use of tDCS improves executive functions. Crucially, the research will advance knowledge of executive function decline as a sensitive marker of PPA, informing us about the possibility of early detection of this disorder. At the same time, the investigators will analyze the possibility of controlling symptomatological evolution via the analysis of acoustic and vocal markers. This will enable us to observe the evolution of sensory markers such as acoustic markers according to symptomatological evolution. This will enable us to check whether acoustic markers correlate with the patient's level of symptomatological impairment and/or pathological physiological data.
- Conditions
- Aphasia, Primary Progressive
- Being tested
- tDCS, SHAM
- 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.
tDCSDevice
Transcranial direct current stimulation of the dorsolateral prefrontal cortex will be made at 1,5mA
SHAMDevice
Transcranial direct current stimulation of the dorsolateral prefrontal cortex will not be made. The electrodes are placed on the skull and a slight but non-continuous intensity is applied.
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Experimental | Not described Receives: Device: tDCS |
| SHAM | Sham comparator | Not described Receives: Device: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flanker task
Measured: 6 week
Stroop task
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start4 Nov 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia, Primary ProgressiveStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Auriane Gros, Pr, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473714
- Sponsor's protocol ID
- 23-AOI-07
- Acronym
- Stim-APHA
- Status last verified
- Nov 2024
- First submitted
- 19 Jun 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation (tDCS) on Inhibition and Brain Function in Primary Progressive Aphasia
- ClinicalTrials.gov ID
- NCT06473714
- Acronym / sponsor ID
- Stim-APHA / 23-AOI-07
- Conditions
- Aphasia, Primary Progressive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 25 Jun 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.
Primary progressive aphasia (PPA) is a focal dementia characterized by primary impairment of language abilities and functional disturbances associated with language.
Although PPA is a progressive disorder, new techniques are being proposed to try to activate parts of the brain previously thought to be potentially inactive, due to the possibility of "neuroplasticity". This concept refers to our brain's modularity and learning potential. Transcranial direct current stimulation is a powerful neuromodulatory technique, in which a small current is applied to the participant's scalp through the targeted positioning of an anode and a cathode. The positive or anodal stimulation of tDCS is supposed to increase neuronal activity under the electrode, while cathodal stimulation is supposed to do the opposite.
This project will provide new insights into the nature of the neural activity underlying executive functions in people with primary progressive aphasia compared to those without. The investigators expect to find reduced amplitude of electrophysiological responses and lower accuracy in people with primary progressive aphasia compared with healthy controls. Given the results of previous studies showing the efficacy of tDCS protocols in the treatment of aphasia, the investigators might expect them to improve executive functions. If so, the investigators expect significantly greater electrophysiological responses after stimulation sessions compared with sham conditions. This project is of great clinical relevance. This research will improve current therapeutic protocols used in the treatment of PPA by providing critical findings on whether and how the use of tDCS improves executive functions. Crucially, the research will advance knowledge of executive function decline as a sensitive marker of PPA, informing us about the possibility of early detection of this disorder. At the same time, the investigators will analyze the possibility of controlling symptomatological evolution via the analysis of acoustic and vocal markers. This will enable us to observe the evolution of sensory markers such as acoustic markers according to symptomatological evolution. This will enable us to check whether acoustic markers correlate with the patient's level of symptomatological impairment and/or pathological physiological data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS | Experimental | Device: tDCS |
| SHAM | Sham comparator | Device: SHAM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be a male or female over the age of 18 with a primary progressive aphasia diagnosis
- Available for treatment and testing sessions
- able to read and speak French
- Be right-handed
Key exclusion criteria (10 listed)
- Presence of neurodevelopmental disorders or non-degenerative neurological disorders
- Post-stroke aphasia
- Language or cognitive disorders too severe to allow task performance or communication
- Pre-existing psychiatric disorders; severe depression, schizophrenia
- People with pacemakers or metal implants, epilepsy
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 |
|---|---|---|
| tDCSTranscranial direct current stimulation of the dorsolateral prefrontal cortex will be made at 1,5mA | Device | tDCS |
| SHAMTranscranial direct current stimulation of the dorsolateral prefrontal cortex will not be made. The electrodes are placed on the skull and a slight but non-continuous intensity is applied. | Device | SHAM |
Primary outcome
Flanker task
Time frame: 6 week
Stroop task
Time frame: 6 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Auriane Gros, Pr contact
Auriane Gros, Pr principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Aphasia, Primary Progressive, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 10 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: looking for participants now, as of the sponsor's last update on 5 Nov 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Auriane Gros, Pr (gros.a2@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flanker task (time frame: 6 week). The study lists 2 primary outcomes in all. 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 5 Nov 2024.