Transcranial Direct Current Stimulation for Primary Progressive Aphasia

NCT ID: NCT02928848

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-16
• Study Completion Date: 2020-03-13

Brief Summary

In the present sham-controlled study, the investigators examine whether tDCS could be used to enhance language abilities (e.g., picture naming) in individuals with primary progressive aphasia (PPA) primarily characterized by difficulties with speech production.

Detailed Description

Primary Progressive Aphasia (PPA) is a neurodegenerative condition characterized by insidious irreversible loss of language abilities. Prior studies suggest that transcranial direct current stimulation (tDCS) directed toward language areas of the brain may help to ameliorate symptoms of PPA. In the current study, the investigators are examining whether tDCS could be used to enhance language abilities (e.g., picture naming) in individuals with PPA variants primarily characterized by difficulties with speech production (non-fluent and logopenic). Participants are being recruited from the Penn Frontotemporal Dementia Center to receive 10 days of both real and sham tDCS (counter-balanced, full-crossover design; participants are naïve to stimulation condition). A battery of language tests are being administered at baseline, immediately post-tDCS (real and sham), and six weeks and twelve weeks following stimulation. Real tDCS may improve language performance in some individuals with PPA. Specifically, the investigators expect that tDCS will be more effective in people whose baseline performance is worse based on previous research. Severity of deficits at baseline may be an important factor in predicting which patients will respond positively to language-targeted tDCS therapies.

Conditions

Primary Progressive Aphasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Real tDCS

Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The stimulation involves 20 minutes of constant stimulation at 1.5 mA.

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The stimulation involves 20 minutes of constant stimulation at 1.5 mA.

Sham tDCS

Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of real tDCS.

Group Type: SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type: DEVICE

Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The stimulation involves 20 minutes of constant stimulation at 1.5 mA.

Interventions

transcranial direct current stimulation

Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The stimulation involves 20 minutes of constant stimulation at 1.5 mA.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Between the ages of 45-80
• Native English speaker
• Diagnosed with Primary Progressive Aphasia
• Subject understands nature of study and able to give informed consent

Exclusion Criteria

• Cognitive impairment of sufficient severity to preclude giving informed consent
• History of seizures or unexplained loss of consciousness
• Previous craniotomy or any breach of the skull
• Metallic objects in the head or face other than dental braces, fillings or implants
• Pacemaker or implantable cardioverter-defibrillator
• Pregnant

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

H B Coslett, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

McConathey EM, White NC, Gervits F, Ash S, Coslett HB, Grossman M, Hamilton RH. Baseline Performance Predicts tDCS-Mediated Improvements in Language Symptoms in Primary Progressive Aphasia. Front Hum Neurosci. 2017 Jun 30;11:347. doi: 10.3389/fnhum.2017.00347. eCollection 2017.

Reference Type: DERIVED

PMID: 28713256 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.med.upenn.edu/lcns/

Lab website

Other Identifiers

818622

Identifier Type: -

Identifier Source: org_study_id