tDCS and Aphasia Therapy in the Acute Phase After Stroke

Not Applicable

Terminated

• Conditions: Aphasia Following Cerebral Infarction
• Interventions: Device: tDCS; Behavioral: Aphasia therapy; Device: Sham-tDCS

• Registration Number: NCT03297450
• Lead Sponsor: University Ghent

Brief Summary

This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in patients in the acute stage 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 acute 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.

Study Timeline

• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-28
• Study First Posted: 2017-09-29
• Study Start: 2017-10-02
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Diagnosed with mild-moderate aphasia (Token Test Score between 7 and 40)
• Inclusion in the first few days after stroke (acute phase)
• Age 18 - 85 years
• Being right-handed
• Mothertongue: Dutch
• Able to undergo functional and specific linguistic testing and therapy in the acute phase following stroke
• Imaging (CT or MRI) prior to inclusion (standard of care)
• Signed Informed Consent

Exclusion Criteria

• History of other diseases of the central nervous system, psychological disorders and (developmental) speech and or language disorders
• Serious non-linguistic, cognitive disorders (as documented in the patients' medical history and inquired in anamneses)
• Prior brain surgery
• Excessive use of alcohol or drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aphasia therapy and tDCS	Aphasia therapy	-
Aphasia therapy and sham-tDCS	Sham-tDCS	-
Aphasia therapy and tDCS	tDCS	-
Standard of care and sham-tDCS	Sham-tDCS	-
Aphasia therapy and sham-tDCS	Aphasia therapy	-

Primary Outcome Measures

Name	Time	Method
Change in naming performance	baseline, 1 week, 3 months, 6 months	Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 and 6 months
Change in Vital Parameters	baseline, 1 hour (each session)	Blood pressure and heart rate will be measured before and after each session of treatment

Secondary Outcome Measures

Name	Time	Method
Change in tolerability (Visual analogue scale)	baseline, 1 hour (each session)	A Visual analogue scale will assess tolerability before and immediately after each session
Change in Spontaneous Speech	baseline, 1 week, 3 months, 6 months	A Semi-standardized interview of the AAT will assess functional communication at baseline, immediately after therapy, and at 3 and 6 months
Change in ERPs	baseline, 1 week, 3 months, 6 months	Evoked potentials will be measured at baseline, immediately after treatment and after 3 and 6 months

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, East-Flanders, Belgium