tDCS and Aphasia Therapy in the Acute Phase After Stroke

Aphasia Following Cerebral Infarction Clinical Trial

Official title:

The Neuromodulatory Effect of Combined Transcranial Direct Current Stimulation (tDCS) With Aphasia Therapy in the Acute Phase After Ischemic Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03297450
• Other study ID #: EC2017/0906
• Status: Terminated
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: January 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia Following Cerebral Infarction
• Cerebral Infarction
• Infarction

Intervention

Device:
• tDCS
C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA

Behavioral:
• Aphasia therapy
Based on linguistic tests, individualized aphasia therapy will be provided

Device:
• Sham-tDCS
tDCS during the first 20 minutes of aphasia therapy at an intensity of 0mA (Sham)

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent	East-Flanders

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in naming performance	Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 and 6 months	baseline, 1 week, 3 months, 6 months
Primary	Change in Vital Parameters	Blood pressure and heart rate will be measured before and after each session of treatment	baseline, 1 hour (each session)
Secondary	Change in tolerability (Visual analogue scale)	A Visual analogue scale will assess tolerability before and immediately after each session	baseline, 1 hour (each session)
Secondary	Change in Spontaneous Speech	A Semi-standardized interview of the AAT will assess functional communication at baseline, immediately after therapy, and at 3 and 6 months	baseline, 1 week, 3 months, 6 months
Secondary	Change in ERPs	Evoked potentials will be measured at baseline, immediately after treatment and after 3 and 6 months	baseline, 1 week, 3 months, 6 months