Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Alzheimer Disease

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT04482179
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Active TMS — DEVICE
    Active TMS will be delivered at 100% motor threshold
  • CILT — BEHAVIORAL
    60-90 minutes of CILT will be administered during each treatment session
  • Sham TMS — DEVICE
    Sham TMS will be administered

Study Details

Impaired verbal communication is a cardinal symptom of Alzheimer Disease (AD) and the source of enormous distress and disability. Effective therapies for this deficit are lacking. In light of the emerging literature demonstrating that Transcranial Magnetic Stimulation (TMS) improves general cognition in subjects with Alzheimer Disease (AD), the investigators propose to study the effectiveness of TMS as a therapy for impaired verbal communication. The hypothesis to be tested is that TMS combined with Constraint Induced Language Therapy (CILT) improves verbal communication more than sham TMS and CILT. A second aim is to use state-of-the-art neuroimaging to understand the mechanisms underlying any beneficial effect of the treatment.

Key Dates

Start date
Feb 19, 2020
Status verified
Aug 2025
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active TMS
    There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
  • Sham Comparator: Sham TMS
    There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz sham TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Sham TMS will be administered with a sham TMS coil that looks and sounds like the active coil but does not generate a magnetic field. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).

Primary Outcome Measure

Change in WAB-AQ Score [ Time Frame: 12 weeks post-treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of Pennsylvania· Philadelphia, PA

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