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NCT05561400

Combining tDCS and CILT in Non-fluent Aphasia

Completed NA Results posted Last updated 9 December 2025
What this trial tests

NA trial testing tDCS in Aphasia in 10 participants. Completed in 15 December 2023.

Timeline
24 April 2023
Primary endpoint
15 December 2023
15 December 2023

Quick facts

Lead sponsorUniversity of Minnesota
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment10
Start date24 April 2023
Primary completion15 December 2023
Estimated completion15 December 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Minnesota

Who can join

18 and older, any sex, with Aphasia or Non-fluent Aphasia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Discourse: Picture Description Primary · Baseline 1: occurred at Visit 2 (after consent)

Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported

GroupValue95% CI
Real tDCS Condition First10± 2.82
Sham tDCS Condition First5.66± 2.08
Discourse Analysis: Picture Description Primary · Follow up 1: Visit 9. 2 weeks after Baseline 1

Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported

GroupValue95% CI
Real tDCS Condition First7.66± 8.02
Sham tDCS Condition First13± 1.41
Discourse: Picture Description Primary · Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after Follow up 1

Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported

GroupValue95% CI
Real tDCS Condition First7± 6.08
Sham tDCS Condition First14± 8.48
Discourse Analysis: Picture Description Primary · Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2

Picture Description using Main Concept Analysis (MCA), a reliable, valid method of discourse analysis. It captures a participant's ability to state the main points/highlights of a sequential story. Responses to the "Broken Window" picture sequence, a normed and standardized task are recorded as accurate and complete (3 points), accurate and incomplete (2 points), inaccurate and complete (2 points), inaccurate and incomplete (1 point) or absent (0points). The minimum score is 0 and the maximum score is 24. There are no subscales. The higher the score, the better the performance. Scores reported

GroupValue95% CI
Real tDCS Condition First11.66± 10.40
Sham tDCS Condition First10± 2.82
Discourse Analysis: Story Retell Primary · Baseline 1: occurred at Visit 2

Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1

GroupValue95% CI
Real tDCS Condition First31± 29.61
Sham tDCS Condition First23± 7.07
Discourse Analysis: Story Retell Primary · Follow up 1: Visit 9: 2 weeks after Baseline 1

Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1

GroupValue95% CI
Real tDCS Condition First31.66± 29.73
Sham tDCS Condition First31± 25.45
Discourse Analysis: Story Retell Primary · Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after follow up 1

Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1

GroupValue95% CI
Real tDCS Condition First33.66± 30.66
Sham tDCS Condition First28.5± 14.84
Discourse Analysis: Story Retell Primary · Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2

Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 102. There are no subscales for this measure. Responses are scored using the following rubric: accurate and complete (3 points), accurate and incomplete (2 point), inaccurate and complete (2 point) inaccurate and incomplete (1

GroupValue95% CI
Real tDCS Condition First35± 30.41
Sham tDCS Condition First26± 16.97
Discourse Analysis: Procedural Primary · Baseline 1: Visit 2

Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inac

GroupValue95% CI
Real tDCS Condition First10± 9.53
Sham tDCS Condition First17± 7.07
Discourse Analysis: Procedural Primary · Follow up 1: Visit 9: 2 weeks after Baseline 1

Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inac

GroupValue95% CI
Real tDCS Condition First11.66± 10.40
Sham tDCS Condition First14± 0
Discourse Analysis: Procedural Primary · Baseline 2: Visit 10. 6 weeks after Baseline 1 and 4 weeks after follow up 1

Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inac

GroupValue95% CI
Real tDCS Condition First14.33± 9.29
Sham tDCS Condition First15± 2.82
Discourse Analysis: Procedural Primary · Follow up 2: Visit 17. 8 weeks after Baseline 1, 6 weeks after Follow up 1 and 2 weeks after Baseline 2

Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful procedural discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The minimum score is 0 and the maximum score is 30. There are no subscales. The higher the score, the better the performance. Participant responses are scored using a rubric: accurate and complete (3 points), accurate and incomplete (2 point)s, inac

GroupValue95% CI
Real tDCS Condition First11.66± 10.11
Sham tDCS Condition First14.5± 3.53

Adverse events — posted to ClinicalTrials.gov

Time frame: Each participant was asked to report adverse events from the following list: headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, lack of concentration, change of mood following all intervention sessions. Each participant was seen for a total of 12 intervention sessions (6 using real tDCS and 6 using sham tDCS). Each participant was asked to report adverse effects immediately following each intervention session.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Real tDCS Condition
Serious: 0/5 (0%)
Deaths: 0/5
Sham tDCS Condition
Serious: 0/5 (0%)
Deaths: 0/5
Other adverse events (9 terms — click to expand)

ReactionSystemReal tDCS ConditionSham tDCS Condition
Tingling sensationGeneral disorders
ItchingGeneral disorders
sleepinessGeneral disorders
Trouble concentratingGeneral disorders
acute change of moodGeneral disorders
HeadacheGeneral disorders
Neck PainGeneral disorders
Burning sensationGeneral disorders
skin rednessGeneral disorders

Data from ClinicalTrials.gov NCT05561400 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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