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Trials / Terminated

TerminatedNCT03305614

TDCS and Aphasia Therapy in the Chronic Phase After Stroke

The Neuromodulatory Effect of Combined Transcranial Direct Current Stimulation with Intensive Aphasia Therapy in the Chronic Phase After Stroke

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
25 (actual)
Sponsor
University Hospital, Ghent · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in patients in the chronic phase after stroke. Half of the participants will receive aphasia therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS.

Detailed description

Aphasia is present in about one third of all stroke patients in the chronic phase. The first few months after stroke, considerable spontaneous recovery is initiated, including neuronal plasticity and reorganization processes. Language recovery in aphasic stroke patients involves reorganization of brain functions. Longitudinal fMRI studies reveal that the right hemisphere shows increased activity at different times in the recovery process, but in the long-term is correlated with poorer performance. Left re-lateralization, if possible, seems to be the most effective in restoring language function. For a large subgroup of patients, aphasia therapy is not sufficient to resolve language deficits and not all patients are capable to endure intensive aphasia therapy. Therefore, non-invasive techniques (NIBS) such as transcranial direct current stimulation (tDCS) are currently explored as an add-on treatment to improve or accelerate therapy outcomes. tDCS is a painless and safe stimulation tool that modulates cortical excitability through weak polarizing currents (1 mA - 2 mA) between two electrodes. These weak currents are thought to induce a subthreshold shift of resting membrane potentials towards depolarization or hyperpolarization. The effects of stimulation depend on the polarity of the applied current relative to the axonal orientation. It has been found that tDCS not only triggers immediate aftereffects, but also long-lasting effects that persist beyond the stimulation time, even for up to 12 months. It was suggested that long-term potentiation (LTP) and long-term depression (LTD) might be responsible for these long-term effects, however the precise physiologic mechanisms of action are not yet fully understood.

Conditions

Interventions

TypeNameDescription
PROCEDUREtDCSC-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA or sham-tDCS at an intensity of 0mA
PROCEDUREAphasia therapyBased on linguistic tests, individualized aphasia therapy will be provided

Timeline

Start date
2017-11-24
Primary completion
2018-04-18
Completion
2018-04-18
First posted
2017-10-10
Last updated
2024-09-19

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03305614. Inclusion in this directory is not an endorsement.