Effects of Transcranial Direct Current Stimulation (tDCS) on Inhibition and Brain Function in Primary Progressive Aphasia

NCT06473714 | Recruiting

• 1 other identifier: 23-AOI-07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (2)

• Flanker task

  6 week

• Stroop task

  6 week

Study Arms (2)

tDCS

EXPERIMENTAL

Device: tDCS

SHAM

SHAM COMPARATOR

Device: SHAM

Interventions

tDCS DEVICE

Transcranial direct current stimulation of the dorsolateral prefrontal cortex will be made at 1,5mA

tDCS

SHAM DEVICE

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.

SHAM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Active use of psychotropic drugs
• Treatment with tDCS or TMS in the last 3 months
• Additional language therapy
• Pregnancy or breast-feeding

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, France

RECRUITING

MeSH Terms

Conditions

Aphasia, Primary Progressive

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Auriane Gros, Pr

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Auriane Gros, Pr

CONTACT

gros.a2@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)