search
Back to results

tDCS and Aphasia Therapy in the Acute Phase After Stroke

Primary Purpose

Aphasia Following Cerebral Infarction

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
tDCS
Aphasia therapy
Sham-tDCS
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia Following Cerebral Infarction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Sham Comparator

Arm Label

Aphasia therapy and tDCS

Aphasia therapy and sham-tDCS

Standard of care and sham-tDCS

Arm Description

Outcomes

Primary Outcome Measures

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
Change in Vital Parameters
Blood pressure and heart rate will be measured before and after each session of treatment

Secondary Outcome Measures

Change in tolerability (Visual analogue scale)
A Visual analogue scale will assess tolerability before and immediately after 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
Change in ERPs
Evoked potentials will be measured at baseline, immediately after treatment and after 3 and 6 months

Full Information

First Posted
September 5, 2017
Last Updated
January 6, 2023
Sponsor
University Ghent
Collaborators
University Hospital, Ghent
search

1. Study Identification

Unique Protocol Identification Number
NCT03297450
Brief Title
tDCS and Aphasia Therapy in the Acute Phase After Stroke
Official Title
The Neuromodulatory Effect of Combined Transcranial Direct Current Stimulation (tDCS) With Aphasia Therapy in the Acute Phase After Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficult patient recruitment
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
University Hospital, Ghent

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia Following Cerebral Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
aphasia therapy (45 minutes) in combination with (sham or real) tDCS (20 minutes)
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aphasia therapy and tDCS
Arm Type
Active Comparator
Arm Title
Aphasia therapy and sham-tDCS
Arm Type
Sham Comparator
Arm Title
Standard of care and sham-tDCS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA
Intervention Type
Behavioral
Intervention Name(s)
Aphasia therapy
Intervention Description
Based on linguistic tests, individualized aphasia therapy will be provided
Intervention Type
Device
Intervention Name(s)
Sham-tDCS
Intervention Description
tDCS during the first 20 minutes of aphasia therapy at an intensity of 0mA (Sham)
Primary Outcome Measure Information:
Title
Change in naming performance
Description
Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 and 6 months
Time Frame
baseline, 1 week, 3 months, 6 months
Title
Change in Vital Parameters
Description
Blood pressure and heart rate will be measured before and after each session of treatment
Time Frame
baseline, 1 hour (each session)
Secondary Outcome Measure Information:
Title
Change in tolerability (Visual analogue scale)
Description
A Visual analogue scale will assess tolerability before and immediately after each session
Time Frame
baseline, 1 hour (each session)
Title
Change in Spontaneous Speech
Description
A Semi-standardized interview of the AAT will assess functional communication at baseline, immediately after therapy, and at 3 and 6 months
Time Frame
baseline, 1 week, 3 months, 6 months
Title
Change in ERPs
Description
Evoked potentials will be measured at baseline, immediately after treatment and after 3 and 6 months
Time Frame
baseline, 1 week, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veerle De Herdt, Prof. Dr.
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

tDCS and Aphasia Therapy in the Acute Phase After Stroke

We'll reach out to this number within 24 hrs