TDCS and Aphasia Therapy in the Chronic Phase After Stroke

NCT03305614 | Terminated Phase 2

• 1 other identifier: BC-136-TVE
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in patients in the chronic phase after stroke. Half of the participants will receive aphasia therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS.

Conditions

Aphasia Following Cerebral Infarction; Aphasia Following Nontraumatic Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Change in naming performance assessed with the Boston Naming Test

  Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 +/- 1 month following treatment

  baseline, 3 weeks, 3 +/-1 month

Secondary Outcomes (4)

• Change in tolerability assessed with a Visual analogue scale

  baseline, 2 hour (each session)

• Change in spontaneous speech assessed with a Semi-standardized interview of the AAT

  baseline, 3 weeks, 3 +/- 1 month

• Change in ERPs

  baseline, 3 weeks, 3 +/- 1 month

• Change in quality of life assessed with the SAQOL-39-NL

  baseline, 3 weeks, 3+/- 1 month

Study Arms (2)

Aphasia therapy and tDCS

ACTIVE COMPARATOR

combined tDCS and aphasia therapy and the effect of conventional intensive aphasia

Procedure: tDCS; Procedure: Aphasia therapy

Aphasia therapy and sham-tDCS

SHAM COMPARATOR

computer-based intensive aphasia therapy as measured by specific linguistic tests

Procedure: Aphasia therapy

Interventions

tDCS PROCEDURE

C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA or sham-tDCS at an intensity of 0mA

Aphasia therapy and tDCS

Aphasia therapy PROCEDURE

Based on linguistic tests, individualized aphasia therapy will be provided

Aphasia therapy and sham-tDCS; Aphasia therapy and tDCS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with mild to moderate aphasia (Token Test Score between 7 and 40) after a first left hemispheric ischemic or hemorrhagic stroke
• Age 18 - 85 years
• Being right-handed (\> +8 on the questionnaire for handedness, Van Strien)
• Mothertongue: Dutch
• Signed Informed Consent (attachment 1)

You may not qualify if:

• 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 the anamneses)
• Prior brain surgery
• Excessive use of alcohol or drugs

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Veerle De Herdt, Prof. Dr.

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 10, 2017
• Study Start: November 24, 2017
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)