TDCS and Aphasia Therapy in the Acute Phase After Stroke

NCT ID: NCT03297450

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2018-03-30

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.

Conditions

Aphasia Following Cerebral Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Aphasia therapy and tDCS

Group Type: ACTIVE_COMPARATOR

tDCS

Intervention Type: DEVICE

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

Aphasia therapy

Intervention Type: BEHAVIORAL

Based on linguistic tests, individualized aphasia therapy will be provided

Aphasia therapy and sham-tDCS

Group Type: SHAM_COMPARATOR

Aphasia therapy

Intervention Type: BEHAVIORAL

Based on linguistic tests, individualized aphasia therapy will be provided

Sham-tDCS

Intervention Type: DEVICE

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

Standard of care and sham-tDCS

Group Type: SHAM_COMPARATOR

Sham-tDCS

Intervention Type: DEVICE

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

Interventions

tDCS

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

Intervention Type: DEVICE

Aphasia therapy

Based on linguistic tests, individualized aphasia therapy will be provided

Intervention Type: BEHAVIORAL

Sham-tDCS

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veerle De Herdt, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

University Hospital Ghent

Ghent, East-Flanders, Belgium

Countries

Belgium

Other Identifiers

EC2017/0906

Identifier Type: -

Identifier Source: org_study_id