Recruiting

Language Function

Sponsor:

University of Arizona

Code:

NCT04920318

Conditions

Primary Progressive Aphasia

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

tDCS + language therapy

sham TDCS + language therapy

Study Details

Brief summary:

This study's goal is to use non-invasive brain stimulation (NBS) techniques to treat language impairment associated with Primary Progressive Aphasia (PPA). The purpose of this study is to combine behavioral language intervention with individualized noninvasive brain stimulation techniques, called transcranial direct current stimulation (tDCS) to help the brain reorganize around damage and improve language functions.

Conditions

Primary Progressive Aphasia

Study ID

NCT04920318

Start date

Aug 30, 2021

Status verified date

Nov, 2024

Completion date

Jun 15, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • diagnosed with PPA by neurologist or speech-language pathologist
  • speech-language deficit arising from PPA
  • native speaker of English Language or equivalent
  • adequate vision (normal or corrected to normal)
  • adequate hearing

Exclusion Criteria:

  • meeting (Diagnostic and Statistical Manual) DSM-IV criteria for Axis I mood, anxiety, psychotic or substance abuse disorders.
  • highly magnetizable metallic implants, including certain dental work
  • neurological disorders besides the ones of interest for the study (e.g., epilepsy)
  • Multiple Sclerosis
  • Parkinson's Disease
  • contraindications for MRI
  • pacemakers
  • metallic cardiac pumps
  • valves
  • magnetic materials such as surgical clips, implanted electronic perfusion pumps, or any other condition that would preclude proximity to a strong magnetic field.
  • clinically significant claustrophobia
  • severe systemic disease (e.g., renal failure)
  • poor health
  • pregnancy
  • epileptic activity in the past 12 months
  • family history of epilepsy or other seizure disorders
  • brain surgery in the past
  • metallic skull plates or implants
  • skin lesions or skull damage
  • excessive use of alcohol or drugs
  • premorbid psychiatric disease affecting communication
  • severe non-linguistic cognitive disturbances impeding language therapy

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: active TDCS

During intervention excitatory/anodal tDCS will be administered alongside speech-language therapy 5 days a week for 2 weeks. The exact location of the stimulation and electrode configuration will be targeted individually based on the optimal site identified in fMRI. TDCS will be administered with NeurConn1 Channel DC- Stimulator Plus (neuroCare Group, München, Germany) according to established guidelines and procedures. The active tDCS will be delivered for 20 minutes using sponge electrodes with a 30-s ramp-up and ramp-down period

sham comparator: sham TDCS

The sham will be administered alongside speech-language therapy 5 days a week for 2 weeks. For sham, stimulation will be ramped up and then down to 0 milliamperes (mA) in the first minute of stimulation. The sham parameters were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade out in the first 30 s of tDCS

Interventions

tDCS + language therapy

In this study fMRI-guided noninvasive neuromodulation will be applied, called Transcranial Direct Current Stimulation (tDCS) to the frontal and parietal brain regions that show reduced activation but still are structurally intact. TDCS will be paired with personalized speech-language therapy to enhance language functions.

sham TDCS + language therapy

sham control will be applied with language therapy to the same regions as active TDCS.

Primary outcome measure

  • Mean change from baseline scores on the Arizona Phonological Battery [ Time Frame: through study completion, an average of 1 year ]
  • Mean change from baseline scores on the naming task [ Time Frame: through study completion, an average of 1 year ]
  • Mean change from baseline scores on the language probe task before and after each session [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Aneta Kielar, PhD

15204883791akielar@email.arizona.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85721-0071

Contacts

Aneta Kielar, PhD

520-488-3791akielar@email.arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Nov 29, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2024-11-29.