Enhancing Language Function in Primary Progressive Aphasia

NCT04920318 | Recruiting FDA Device

• 1 other identifier: 2103570362
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Mean change from baseline scores on the Arizona Phonological Battery

  Mean change from baseline scores on the Arizona Phonological Battery: Minimum score = 0; maximum = 100%; higher scores indicate better outcome

  through study completion, an average of 1 year

• Mean change from baseline scores on the naming task

  Mean change from baseline scores on the Boston Naming Test: Min score = 0; Max = 60; higher scores indicate better outcome

  through study completion, an average of 1 year

• Mean change from baseline scores on the language probe task before and after each session

  change on on the probe task from before the session; Min =0; Max = 100%; higher scores indicate better outcome

  through study completion, an average of 1 year

Study Arms (2)

active TDCS

EXPERIMENTAL

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

Combination Product: tDCS + language therapy

sham TDCS

SHAM COMPARATOR

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

Combination Product: sham TDCS + language therapy

Interventions

tDCS + language therapy COMBINATION_PRODUCT

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.

Also known as: active tDCS, transcranial direct current simulation (tDCS)

active TDCS

sham TDCS + language therapy COMBINATION_PRODUCT

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

Also known as: sham transcranial direct current simulation (tDCS)

sham TDCS

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721-0071, United States

RECRUITING

MeSH Terms

Conditions

Aphasia, Primary Progressive

Interventions

Transcranial Direct Current Stimulation; Language Therapy

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; Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Aneta Kielar, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aneta Kielar, PhD

CONTACT

15204883791; akielar@email.arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The subject codes will be used for blinding of the participants, care-providers, and speech-language therapist administering the treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: individuals diagnosed with Alzheimer's Disease Primary Progressive Aphasia (AD-PPA) (\~50-80 years old) will be randomized to receive active tDCS+language treatment or sham (fake tDCS)+language treatment in a cross-over design.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 9, 2021
• Study Start: August 30, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)