AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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

gros.a2@chu-nice.fr

France1 site, 1 recruiting
  • CHU de Nice

    Nice

    Justine LEMAIRE, +33492034778

    Recruiting

Other trials in France

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.

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 groups in NCT06473714
Study groupRoleWhat they receive
tDCSExperimentalNot described
Receives: Device: tDCS
SHAMSham comparatorNot described
Receives: Device: SHAM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Flanker task

    Measured: 6 week

  2. 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.

  1. First posted25 Jun 2024
  2. Study start4 Nov 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in