Trial results for a study investigating the combination of transcranial direct current stimulation (tDCS) and Constraint-Induced Language Therapy (CILT) for non-fluent aphasia after stroke were posted on ClinicalTrials.gov on 2025-12-09, with 10 participants enrolled.
Background
Aphasia, particularly non-fluent aphasia, is a common and often debilitating consequence of stroke and other brain injuries, significantly impacting an individual's ability to communicate. Current rehabilitation strategies aim to improve language function, but outcomes can vary. This study explored the potential benefits of combining a highly intensive, task-specific behavioral language intervention, Constraint-Induced Language Therapy (CILT), with neuromodulation via transcranial direct current stimulation (tDCS). The long-term goal is to assess if this combined approach can positively influence discourse, verbal fluency, and working memory in individuals with non-fluent aphasia after stroke, and if these changes correlate with neuroplastic changes in the cerebellar-cortical pathway.
Trial design
This completed study, designated as Phase NA, enrolled 10 participants. The trial investigated conditions including Aphasia, Non-fluent Aphasia, Stroke, and Brain Injuries. The intervention involved combining transcranial direct current stimulation (tDCS) with Constraint-Induced Language Therapy (CILT). Participants were assigned to either a "Real tDCS Condition First" group or a "Sham tDCS Condition First" group, indicating a design to compare the active intervention against a sham control.
Key results
The trial reported several key measurements related to discourse and discourse analysis:
- Discourse: Picture Description (score on a scale):
- For the "Real tDCS Condition First" group, a mean score of 10 (Standard Deviation 2.82) was observed.
- For the "Sham tDCS Condition First" group, a mean score of 5.66 (Standard Deviation 2.08) was observed.
- Another measurement for the "Real tDCS Condition First" group showed a mean score of 7 (Standard Deviation 6.08).
- For the "Sham tDCS Condition First" group, another measurement showed a mean score of 14 (Standard Deviation 8.48).
- Discourse Analysis: Picture Description (Raw Score/Points or score on a scale):
- For the "Real tDCS Condition First" group, a mean score of 7.66 (Standard Deviation 8.02) was observed (Raw Score/Points).
- For the "Sham tDCS Condition First" group, a mean score of 13 (Standard Deviation 1.41) was observed (Raw Score/Points).
- Another measurement for the "Real tDCS Condition First" group showed a mean score of 11.66 (Standard Deviation 10.40) (score on a scale).
- For the "Sham tDCS Condition First" group, another measurement showed a mean score of 10 (Standard Deviation 2.82) (score on a scale).
- Discourse Analysis: Story Retell (score on a scale):
- For the "Real tDCS Condition First" group, a mean score of 31 (Standard Deviation 29.61) was observed.
- For the "Sham tDCS Condition First" group, a mean score of 23 (Standard Deviation 7.07) was observed.
- Another measurement for the "Real tDCS Condition First" group showed a mean score of 31.66 (Standard Deviation 29.73).
- For the "Sham tDCS Condition First" group, another measurement showed a mean score of 31 (Standard Deviation 25.45).
What this means
The posted results offer preliminary data from a small pilot study investigating the combination of tDCS and CILT for individuals with non-fluent aphasia after stroke. With only 10 participants, these measurements provide initial insights into various discourse and language outcomes under both real and sham tDCS conditions. While specific mean scores and standard deviations are reported for different assessment tools, no comparative analyses or statistical significance values are available in the provided data. Therefore, these findings contribute to the foundational understanding of this experimental approach but do not yet support definitive conclusions regarding efficacy or clinical impact. Further research with larger cohorts and robust statistical analysis would be necessary to determine the therapeutic potential of this combined intervention.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05561400, titled "Combining tDCS and CILT in Non-fluent Aphasia", were posted on 2025-12-09 on clinicaltrials.gov.