Combining tDCS and CILT in Non-fluent Aphasia

Part of paid clinical trials in Duluth, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05561400
Status
Completed

Conditions

  • Aphasia
  • Brain Injuries
  • Non-fluent Aphasia
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tDCS — DEVICE
    5x5 saline-soaked sponge electrodes will be used with the cathode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the anode will be placed on the right shoulder. The electrode placement will be the same across both conditions.
  • Placebo — OTHER
    sham tDCS to the right cerebellum

Study Details

The long-term goal of this work is to determine if combining a highly intensive, task-specific behavioral language intervention with modulation of the efferent cerebellar-cortical pathway using transcranial direct current stimulation (tDCS) has a positive influence on discourse, verbal fluency and working memory in individuals with non-fluent aphasia after stroke. And if these changes can be related to neuroplastic change in the cerebellar cortical pathway indirectly measured through neurophysiologic changes using spectral electroencephalogram (EEG). The initial phase includes the proposed pilot study data from which will be used to inform a larger clinical trial. The primary aims of this pilot are to 1) determine the effect of combining cerebellar tDCS with constraint-induced language therapy (CILT) on language as measured by a verbal fluency task and discourse task in a small population and 2) identify the tolerance of the intervention and barriers to participation measured by the adverse events questionnaire that will inform the methodology of a larger study. The secondary aims include estimating the size of the treatment effect on 1) delta percentage in F3, F7 and Fp1 compared to F4, F8, and Fp2 using resting state EEG spectral analysis and coherence, 2) working memory as measured by the score on the n-back test and 3) quality of life as measured by the Stroke Aphasia Quality of Life survey tool. The secondary aims will be used to determine the utility of these measures in a larger clinical trial. This is a prospective, crossover study, sham-controlled intervention study with two intervention conditions delivered across 6 intervention sessions (3x/week for two weeks) with a 4-week washout in between. Conditions include: 1) sham cerebellar tDCS and 2) real cerebellar tDCS delivered at 2mA across 20 minutes. Each of these will be delivered during CILT intervention with a licensed, certified speech-language pathologist trained in CILT. Once tDCS stimulation has ended, CILT will continue to be delivered for an additional 25 minutes. Assessments of discourse, verbal fluency, working memory and EEG spectral analysis will be conducted at four timepoints, before and after each intervention phase.

Key Dates

Start date
Apr 24, 2023
Status verified
Nov 2025
Primary completion
Dec 15, 2023
Completion
Dec 15, 2023

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Real tDCS
    the participant receives real tDCS to the right cerebellum during behavioral intervention (CILT)
  • Placebo Comparator: Sham tDCS
    the participant receives sham tDCS to the right cerebellum during behavioral intervention (CILT)

Primary Outcome Measure

Discourse: Picture Description [ Time Frame: Baseline 1: occurred at Visit 2 (after consent) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaDuluthMinnesota55812-

Find similar trials in Duluth, MN

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Minnesota· Duluth, MN

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