Treating Primary Progressive Aphasia and Apraxia of Speech Using Non-invasive Brain Stimulation

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Primary Progressive Aphasia; Apraxia of Speech

Treatments: Device: high-definition transcranial direct current stimulation (HD-tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05368350

UTD IRB: 24-595

Details and patient eligibility

About

The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., pre-supplementary motor area and left inferior frontal gyrus) thought to aid in memory will improve speech and language difficulties in patients with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS). The primary outcome measures are neuropsychological assessments of speech and language functions, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures.

Full description

This pilot study has one treatment arm with open-label treatment and will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area or left inferior frontal gyrus for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.

All patients with a clinical diagnosis of PPA or PAOS will be assigned to either one of the two open-label arms to receive active tDCS. Primary outcome speech and language measures, secondary neuropsychological and electroencephalography (EEG) measures, and pre-screening assessments for study medical history and contraindications for treatment will be collected prior to the treatment (i.e., baseline).

Primary outcome speech and language functions measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected after treatment session 10 and following treatment competition (i.e., 8-week).

Enrollment: 12 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 85 years of age
• A formal diagnosis of primary progressive aphasia (nonfluent/agrammatic, semantic, logopenic variants or mixed) and/or progressive apraxia of speech
• Capable of understanding and signing an informed consent. Medical information/history, as well as mental status exam and diagnosis provided by referring physician will determine whether or not a caregiver is required to be involved during this process.

Exclusion criteria

• Has an implanted device, such as a pacemaker, metallic cranial implant, or a neurostimulator
• Skull defects
• Pregnant
• A significant history of arrhythmia or epileptic seizures.
• Not a native English speaker
• Currently receiving speech-language intervention
• Unable to communicated verbally

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

Active Pre-SMA tDCS treatment

Experimental group

Description:

This open-label treatment will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.

Treatment:

Device: high-definition transcranial direct current stimulation (HD-tDCS)

Active LIFG tDCS treatment

Experimental group

Description:

This open-label treatment will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to left inferior frontal gyrus for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.

Treatment:

Device: high-definition transcranial direct current stimulation (HD-tDCS)