NCT05978804

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

Remote Home-based Electrical Stimulation (tDCS) in Primary Progressive Aphasia (With Frontotemporal Dementia or Alzheimer's Pathology) and Mild Cognitive Impairment/Alzheimer's.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Detailed description

In this within-subject cross-over protocol, all participants will receive both, cognitive training and brain stimulation tDCS. Participants will be randomly assigned to begin with either cognitive training and brain stimulation (dual therapy) or just brain stimulation (monotherapy) and will receive the complementary therapy program in the second round of treatment. During each period of therapy, participants will receive 50 treatment sessions over the course of approximately 10 weeks. The computerized cognitive training and brain stimulation will both be preprogrammed to be done at home by the participant.

Conditions

• Mild Cognitive Impairment
• Primary Progressive Aphasia
• Dementia

Interventions

Type	Name	Description
OTHER	Computerized Cognitive Training	Computerized Cognitive training (BrainHQ or Constant Therapy)
DEVICE	Active tDCS (tDCS) on DLPFC	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.

Timeline

• Start date: 2023-08-10
• Primary completion: 2025-09-10
• Completion: 2025-09-10
• First posted: 2023-08-07
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study