Rehabilitating and Decelerating Language Loss in Primary Progressive Aphasia With tDCS Plus Language Therapy

NCT03728582 | Completed Results FDA Device

• 1 other identifier: IRB00174879
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

People with Primary Progressive Aphasia (PPA) are is a debilitating disorder characterized by the gradual loss of language functioning, even though cognitive functioning is relatively well preserved until the advanced stages of the disease. There are very few evidence-based treatment options available. This study investigates the behavioral and neural effects of multiple consecutive tDCS sessions paired with language therapy targeting verbs in sentences with individuals with PPA.

Conditions

Primary Progressive Aphasia; PPA

Keywords

Aphasia; Language therapy; Neurocognitive Disorders; Frontotemporal Dementia; Dementia; Anomia

Outcome Measures

Primary Outcomes (1)

• Change in Accuracy of Naming Trained Verbs (0 to 15, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery (OANB)

  To determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition). The primary outcome variable will be trained verbs on the Object and Action Naming battery (OANBtrained). The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities. The OANB includes 100 verbs (15 trained, 85 untrained) and 162 nouns.

  Baseline, and 4-7 weeks after treatment begins

Secondary Outcomes (5)

• Change in Accuracy of Naming Untrained Verbs (0 to 85, Higher Scores Reflect Better Naming Abilities) and Nouns (0 to 162, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery

  Baseline, and 4-7 weeks after treatment begins

• Change in Accuracy of Naming Trained Verbs (0 to 15, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery

  Baseline, and 2 months after treatment ends

• Change in Accuracy of Naming Untrained Verbs (0 to 85, Higher Scores Reflect Better Naming Abilities) and Untrained Nouns (0 to 162, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery

  Baseline, and 2 months after treatment ends

• Change in Functional Communication Skills as Assessed by the Functional Assessment of Communication Skills for Adults (ASHA FACS)

  Baseline, and 4-7 weeks after treatment begins

• Change in Functional Communication Skills as Assessed by the Functional Assessment of Communication Skills for Adults (ASHA FACS)

  Baseline, and 2 months after treatment ends

Study Arms (2)

Active tDCS plus Speech-Language Therapy

EXPERIMENTAL

Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be verb naming therapy in a sentence context. This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period.

Device: Active tDCS plus Speech-Language Therapy; Device: Sham tDCS plus Speech-Language Therapy

Sham plus Speech-Language Therapy

SHAM COMPARATOR

Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. Language therapy will be verb naming therapy in a sentence context. This will be followed by active tDCS plus speech-language therapy after a 2 month washout period.

Device: Active tDCS plus Speech-Language Therapy; Device: Sham tDCS plus Speech-Language Therapy

Interventions

Active tDCS plus Speech-Language Therapy DEVICE

1-2 milliamps (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be verb naming therapy in a sentence context.

Also known as: Active tDCS and speech-therapy

Active tDCS plus Speech-Language Therapy; Sham plus Speech-Language Therapy

Sham tDCS plus Speech-Language Therapy DEVICE

Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy will be verb naming therapy in a sentence context.

Active tDCS plus Speech-Language Therapy; Sham plus Speech-Language Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PPA, based on the PPA criteria and presence of naming deficits
• Capable of giving informed consent or indicating another to provide informed consent
• years of age to 100 years of age..

You may not qualify if:

• Did not speak English before the age of five
• Less than 10 years of education
• Severe naming deficits
• Significant history of drug or alcohol abuse
• History of psychiatric or neurological problems affecting the brain (besides PPA)
• Has experienced seizures during the previous 12 months
• History of brain surgery or any metal in the head
• Uncorrected visual loss or hearing loss by self-report
• Use of medications that lower the seizure threshold (e.g., methylphenidate) or use of N-Methyl-D-aspartate (NMDA) receptor antagonists (e.g., memantine)
• Scalp sensitivity (per participant report)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Aphasia, Primary Progressive; Aphasia; Neurocognitive Disorders; Frontotemporal Dementia; Dementia; Anomia

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Argye Hillis
• Organization: Johns Hopkins University

argye@jhmi.edu

(443) 287-4610

Study Officials

• Shannon M Sheppard, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Model Details: Crossover assignment

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 2, 2018
• Study Start: October 10, 2018
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: April 27, 2023
• Results First Posted: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)