search
Back to results

Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Naming in Aphasic Patients.

Primary Purpose

Stroke, Aphasia

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
HD-tDCS
Sponsored by
Adrian Guggisberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring tDCS, Functional connectivity, EEG

Eligibility Criteria

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

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke
  • Presence of aphasia with difficulty finding words and/or naming objects/pictures
  • ≥12 months post-stroke
  • ≥ 18 years of age
  • French-speaking
  • Able to participate in 30-60 min therapeutic sessions (good concentration and understanding of the task and ability to follow instructions

Exclusion Criteria:

  • Patients unable to understand the given information on the study and its objectives, or instructions for tasks performed.
  • Impaired alertness or delirium
  • Severe co-morbidity affecting speech
  • Contraindication to tDCS: pregnant women, patients with active implants such as pacemakers or cochlear implants, patients with one or more seizures, metal objects in the brain
  • Occurrence of a new stroke during the study protocol.

Sites / Locations

  • Division of Neurorehabilitation, University Hospital of GenevaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

HD-tDCS

sham-tDCS

Arm Description

high-density transcranial direct current stimulation (HD-tDCS) over Broca's area

sham transcranial direct current stimulation. The same setup will be used as in the HD-tDCS arm, except that the current will be ramped up for 30 seconds and then switched off. This does not lead to neural effects, but the patients have a similar sensation.

Outcomes

Primary Outcome Measures

Action picture naming, short-term improvement
Change in number of correctly named action pictures

Secondary Outcome Measures

Functional connectivity between Broca's and Wernicke's area
Change in the normalized imaginary component of coherence between Broca and Wernicke

Full Information

First Posted
October 4, 2022
Last Updated
November 1, 2022
Sponsor
Adrian Guggisberg
search

1. Study Identification

Unique Protocol Identification Number
NCT05570578
Brief Title
Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Naming in Aphasic Patients.
Official Title
Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Naming
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adrian Guggisberg

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.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
High-Definition Transcranial Direct Current Stimulation (HD-tDCS) allows to induce, in a non-invasive way, a transient inhibitory or excitatory neuromodulation of a given cerebral region and to obtain a very focused cortical effect. Previous studies using HD-tDCS have shown the effectiveness of this stimulation technique for enhancing language recovery in patients with aphasia. However, language processes are not determined solely by local neural activity at a single site, but rather by the interaction between neural networks. This is because a large cortical network is involved in language processes and, therefore, the same language disorder may result from lesions at different locations in this network. The investigators hypothesize that anodal HD-tDCS will enhance neural interactions between language areas and, thereby, improve language processing and word learning. The investigators propose to carry out a study on chronic aphasic patients involving HD-tDCS of the Broca region (left inferior frontal gyrus) combined with a verb learning task.
Detailed Description
Functional connectivity (FC) represents a means of analyzing functional interactions in the brain network by assessing the statistical dependence of neural activity between brain areas. The brain maintains a high level of interactions between brain areas even in the resting state, when it is not explicitly involved in a specific task. Resting-state interactions occur mainly in the so-called alpha frequency band (8-13 Hz) . Moreover, these resting-state interactions are crucial for correct task performance and learning. Indeed, healthy subjects with high resting-state alpha-band FC levels are better able to perform tasks and learn. For example, subjects with high levels of FC between Broca's area and the rest of the brain perform better on language production tasks and show greater training gains when learning new words. In addition, patients with brain damage due to stroke show a reduction in resting-state alpha-band FC, which correlates with the severity of neurological deficits. In particular, a loss of FC of structurally preserved inferior frontal areas was associated with more severe aphasia. Conversely, high-levels of FC between the inferior frontal brain areas and the rest of the brain during the first weeks after stroke was associated with better recovery from aphasia, probably reflecting a reorganization of neural connections as a neural mechanism involved in plasticity. Resting-state FC is therefore an interesting neural target for therapy, which could help improve recovery from aphasia. In a previous study on healthy subjects, the investigators have indeed observed that HD-tDCS applied to Broca's area improves the ability for new-verb learning, i.e., the correct naming of action pictures. This improvement in learning correlated with greater increase in FC between Broca's and Wernicke's area. The investigators now carry out a study on chronic aphasic patients involving HD-tDCS of the Broca region (left inferior frontal gyrus) combined with a verb learning task.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia
Keywords
tDCS, Functional connectivity, EEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
sham-tDCS
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HD-tDCS
Arm Type
Active Comparator
Arm Description
high-density transcranial direct current stimulation (HD-tDCS) over Broca's area
Arm Title
sham-tDCS
Arm Type
Sham Comparator
Arm Description
sham transcranial direct current stimulation. The same setup will be used as in the HD-tDCS arm, except that the current will be ramped up for 30 seconds and then switched off. This does not lead to neural effects, but the patients have a similar sensation.
Intervention Type
Device
Intervention Name(s)
HD-tDCS
Other Intervention Name(s)
high-density transcranial direct current stimulation, DC-stimulator
Intervention Description
The anode electrode will be placed over Broca's area, 4 cathode electrodes will be placed at about 2 cm distance each from the anode in 4 directions.
Primary Outcome Measure Information:
Title
Action picture naming, short-term improvement
Description
Change in number of correctly named action pictures
Time Frame
Change from day 1 (baseline) to day 5 (posttest)
Secondary Outcome Measure Information:
Title
Functional connectivity between Broca's and Wernicke's area
Description
Change in the normalized imaginary component of coherence between Broca and Wernicke
Time Frame
Change from day 1 (baseline) to day 5 (posttest)
Other Pre-specified Outcome Measures:
Title
Action picture naming, long-term improvement
Description
Change in number of correctly named action pictures
Time Frame
Change from day 1 (baseline) to week 4 (follow-up)
Title
Narrative speech, short-term improvement
Description
Patient describes cookie-theft picture and action-picture, change in score
Time Frame
Change from day 1 (baseline) to day 5 (posttest)
Title
Narrative speech, long-term improvement
Description
Patient describes cookie-theft picture and action-picture, change in score
Time Frame
Change from day 1 (baseline) to week 4 (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ischemic or hemorrhagic stroke Presence of aphasia with difficulty finding words and/or naming objects/pictures ≥12 months post-stroke ≥ 18 years of age French-speaking Able to participate in 30-60 min therapeutic sessions (good concentration and understanding of the task and ability to follow instructions Exclusion Criteria: Patients unable to understand the given information on the study and its objectives, or instructions for tasks performed. Impaired alertness or delirium Severe co-morbidity affecting speech Contraindication to tDCS: pregnant women, patients with active implants such as pacemakers or cochlear implants, patients with one or more seizures, metal objects in the brain Occurrence of a new stroke during the study protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adrian G Guggisberg, MD
Phone
+41316323081
Email
Adrian.Guggisberg@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian G Guggisberg, MD
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Neurorehabilitation, University Hospital of Geneva
City
Geneva
State/Province
GE
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian G Guggisberg, MD
Phone
+41223723521
Email
adrian.guggisberg@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Adrian G Guggisberg, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Published and analyzed data will be archived in a secure location on a data sharing server that meets the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles for a minimum of 10 years.
IPD Sharing Time Frame
Once the study has been published
IPD Sharing Access Criteria
Open Access

Learn more about this trial

Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Naming in Aphasic Patients.

We'll reach out to this number within 24 hrs