tDCS and Aphasia Therapy in the Acute Phase After Stroke

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

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.

Study Overview

• Status: Terminated
• Conditions: Aphasia Following Cerebral Infarction
• Intervention / Treatment: Device: tDCS; Behavioral: Aphasia therapy; Device: 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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • East-Flanders
    • Ghent, East-Flanders, Belgium, 9000
      • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aphasia therapy and tDCS	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
Sham Comparator: Aphasia therapy and sham-tDCS	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)
Sham Comparator: Standard of care and sham-tDCS	Device: Sham-tDCS; tDCS during the first 20 minutes of aphasia therapy at an intensity of 0mA (Sham)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tolerability (Visual analogue scale)	A Visual analogue scale will assess tolerability before and immediately after each session	baseline, 1 hour (each session)
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
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

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Brain Ischemia; Stroke; Brain Infarction; Language Disorders; Communication Disorders; Speech Disorders; Infarction; Cerebral Infarction; Aphasia
• Other Study ID Numbers: EC2017/0906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes