TDCS and Aphasia Therapy in the Acute Phase After Stroke

NCT03297450 | Terminated

• 1 other identifier: EC2017/0906
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia Following Cerebral Infarction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in tolerability (Visual analogue scale)

  baseline, 1 hour (each session)

• Change in Spontaneous Speech

  baseline, 1 week, 3 months, 6 months

• Change in ERPs

  baseline, 1 week, 3 months, 6 months

Study Arms (3)

Aphasia therapy and tDCS

ACTIVE COMPARATOR

Device: tDCS; Behavioral: Aphasia therapy

Aphasia therapy and sham-tDCS

SHAM COMPARATOR

Behavioral: Aphasia therapy; Device: Sham-tDCS

Standard of care and sham-tDCS

SHAM COMPARATOR

Device: Sham-tDCS

Interventions

tDCS DEVICE

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

Aphasia therapy and tDCS

Aphasia therapy BEHAVIORAL

Based on linguistic tests, individualized aphasia therapy will be provided

Aphasia therapy and sham-tDCS; Aphasia therapy and tDCS

Sham-tDCS DEVICE

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

Aphasia therapy and sham-tDCS; Standard of care and sham-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-moderate aphasia (Token Test Score between 7 and 40)
• 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
• Signed Informed Consent

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 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: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: aphasia therapy (45 minutes) in combination with (sham or real) tDCS (20 minutes)

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 29, 2017
• Study Start: October 2, 2017
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: September 19, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)