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NCT05561400Completed

Combining tDCS and CILT in Non-fluent Aphasia

Combining Cerebellar tDCS and Constraint-induced Language Therapy in Non-fluent Aphasia: a Novel Approach to Target Discourse

Source: ClinicalTrials.gov · Last updated 9 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
10 (actual)
First submitted
23 Jun 2022
Start date
24 Apr 2023
Primary completion date
15 Dec 2023
Lead sponsor
University of Minnesota
Diseases
Stroke
NCT number
NCT05561400

What you commit to

  • Study type: Interventional
  • Participants enrolled: 10
  • From 24 Apr 2023 to the primary completion date, 15 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • any metal implants in the body (excluding dental fillings),

Other illness

  • history of seizures,
  • history of migraines,
  • history of a head injury such as a concussion
  • diagnosis of a mental health or neurological condition/disease.

Other

  • Pregnancy,
  • psoriasis or eczema affecting the scalp,

Who the study is looking for

  • over the age of 18 years
  • history of stroke
  • diagnosed with non-fluent aphasia.
  • be able to independently understand simple directions,
  • use some speech to communicate,
  • have access to reliable transportation (including taxi and/or other transportation services),
  • fluent in English.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Minnesota
Coordinator of this site? Confirm its status
DuluthUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.