Home-based tDCS in Frontotemporal Dementia or Alzheimer's Disease

NCT05978804 | Terminated FDA Device

• 1 other identifier: NA_00071337-4
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this research is to evaluate the effects of non-invasive brain stimulation and computerized cognitive training on executive functioning in individuals with Primary Progressive Aphasia (PPA), mild cognitive impairment (MCI), or dementia. In this study, investigators will use transcranial direct current stimulation (tDCS) to stimulate the left dorsolateral prefrontal cortex (DLPFC). Previous studies have demonstrated that tDCS over the DLPFC led to improvements in attention deficit caused by stroke, Parkinson's Disease, and major depression as well as language deficits caused by neurodegenerative conditions such as primary progressive aphasia or mild cognitive impairment. The investigators seek to expand on this literature by investigating how anodal tDCS paired with and without cognitive training will impact executive functioning in PPA with Frontotemporal Dementia or Alzheimer's Disease pathology and Mild Cognitive Impairment/Alzheimer's Disease (e.g. shifting, updating, monitoring, and manipulation).

Conditions

Mild Cognitive Impairment; Primary Progressive Aphasia; Dementia

Outcome Measures

Primary Outcomes (3)

• Change in language composite outcome

  A single language composite outcome will be generated by computing the mean of the z-scores the following oral and written naming, spelling, and sentence comprehension and repetition tasks: Philadelphia Naming Test (Short Form), Boston Naming Test, Hopkins Action Naming Assessment, Hopkins Dysgraphia Battery, National Alzheimer's Coordinating Center Sentence Repetition. The investigators will take the z-score for each task and aggregate them in order to get a composite z-score.

  Before intervention, immediately after intervention

• Change in Executive Composite Outcome

  A single executive composite will be generated by computing the mean of the z-scores of the tasks below reflecting new learning and memory, processing speed and executive functioning, attention and working memory, and verbal fluency respectively: Rey Auditory Verbal Learning Test, Trail Making Test A and B, Attention Network Task, Digit and Spatial Span, and Category fluency and Verbal Fluency. The investigators will take the z-score for each task and aggregate them in order to get a composite z-score.

  Before intervention, immediately after intervention

• Change in Global Cognitive Scores

  This will be measured using the Montreal Cognitive Assessment (MoCA). Scored out of 30 points, higher is better.

  Before intervention, immediately after intervention

Secondary Outcomes (3)

• Change in Selective attention and cognitive flexibility

  Before intervention, immediately after intervention

• Change in attention and task switching

  Before intervention, immediately after intervention

• Change in working memory capacity.

  Before intervention, immediately after intervention

Study Arms (2)

Active tDCS on the DLPFC + Cognitive Intervention(s)

EXPERIMENTAL

Participants will receive active tDCS on DLPFC + Cognitive Intervention(s) first and then receive only active tDCS Intervention after a three-month washout period.

Other: Computerized Cognitive Training; Device: Active tDCS (tDCS) on DLPFC

Active tDCS on the DLPFC only

EXPERIMENTAL

Participants will receive active tDCS on the DLPFC-only intervention first and then receive active tDCS + Cognitive Intervention(s) after a three-month washout period.

Device: Active tDCS (tDCS) on DLPFC

Interventions

Computerized Cognitive Training OTHER

Computerized Cognitive training (BrainHQ or Constant Therapy)

Active tDCS on the DLPFC + Cognitive Intervention(s)

Active tDCS (tDCS) on DLPFC DEVICE

Device: Active tDCS on DLPFC Stimulation will be delivered by a constant current stimulator (Mind STIM). The electrical current will be administered to a pre-specified region of the brain (DLPFC). The stimulation will be delivered at an intensity of 2 milliamperes (mA) (estimated current density 0.04 mA/cm2; estimated total charge 0.048 Coulombs/cm2) in a ramp-like fashion for a maximum of 20 minutes.

Active tDCS on the DLPFC + Cognitive Intervention(s); Active tDCS on the DLPFC only

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be clinically diagnosed with PPA, fronto-temporal dementia (FTD), MCI or mild Alzheimer's disease (AD). Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI, and clinical assessment.
• Must be right-handed.
• Must be proficient in English.
• Must have a minimum high-school education.

You may not qualify if:

• Uncorrected visual or hearing impairment by self-report.
• Stroke/other premorbid neurological disorder affecting the brain.
• Any other developmental language-based learning disorder other than PPA.
• Inability to follow directions for baseline tasks.
• Pre-existing psychiatric disorders such as behavioral disturbances, severe depression, and schizophrenia that do not allow them to comply or follow the study schedule and requirements such as repeated evaluation and therapy will be excluded.
• Severe claustrophobia.
• Cardiac pacemakers or ferromagnetic implants.
• Pregnant women.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Ybrain Inc.: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Aphasia, Primary Progressive; Dementia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; 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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Kyrana Tsapkini, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects meeting eligibility criteria will be randomized to receive either tDCS + cognitive training or only tDCS. After 50 treatment sessions (approximately 10 weeks) participants will switch to the other condition.

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 7, 2023
• Study Start: August 10, 2023
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)