Combining Language Therapy With rTMS in Aphasia

NCT03629665 | Completed

• 1 other identifier: HelsinkiUniversity/Logopedics
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

With the present RCT, the investigators aimed at finding an optimal protocol for the neurorehabilitation of chronic post-stroke aphasia by combining two promising methods, ILAT (Intensive language action therapy) and 1-Hz rTMS to the right-hemispheric homologue of the anterior language area of Broca (pars triangularis), thus taking advantage of recent research in speech and language sciences, neurorehabilitation and brain research.

Conditions

Aphasia

Keywords

chronic aphasia; rehabilitation; randomized controlled trial (RCT)

Outcome Measures

Primary Outcomes (1)

• The Western Aphasia Battery

  aphasia quotient (AQ) measurement

  Change in AQ performed at weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion

Secondary Outcomes (2)

• The Boston naming test

  Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion

• The Action naming test

  Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion

Study Arms (2)

rTMS and naming combined with ILAT

ACTIVE COMPARATOR

Interventions: Repetitive navigated Transcranial Magnetic Stimulation, picture naming and Intensive Language Action Therapy

Behavioral: Intensive Language-Action Therapy (ILAT); Device: Repetitive navigated Transcranial Magnetic Stimulation during naming training

sham rTMS and naming combined with ILAT

SHAM COMPARATOR

Interventions: sham Repetitive navigated Transcranial Magnetic Stimulation, picture naming and Intensive Language Action Therapy

Behavioral: Intensive Language-Action Therapy (ILAT)

Interventions

Repetitive navigated Transcranial Magnetic Stimulation during naming training DEVICE

Magnetic stimulation will delivered with a figure-of-eight cooled coil of Navigated Brain Stimulation System during picture naming training. The primary targeted area is the right pars triangularis. In each session, rTMS will be applied at 1-Hz for 20 minutes, 5 daily sessions per week for four weeks.

rTMS and naming combined with ILAT

Intensive Language-Action Therapy (ILAT) BEHAVIORAL

ILAT includes communicative language games played in an interactive small-group setting. Three persons with aphasia and one therapist sit around a table and have picture cards in front of them. The card sets include two items of each object or action picture. All participants take turns in making verbal requests. There will be 5 daily sessions (3 hours per session) for two weeks.

rTMS and naming combined with ILAT; sham rTMS and naming combined with ILAT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 75 years
• presence of a single clinically documented stroke
• chronic stage (at least 12 months post-stroke)
• aphasia documented using the WAB test
• no recurring utterances or severe global (total) aphasia
• residual ability to understand simple task instructions
• availability of information about medication
• right-handedness
• native speakers of Finnish.

You may not qualify if:

• severe global (total) aphasia (Boston naming test less 3 points)
• neglect, agnosia, severe vision impairment or hearing loss
• severe attention or memory deficits
• left-handedness
• cardiac pacemaker or other stimulators
• diagnosis of severe diabetes or severe depression
• additional neurological diagnoses
• other interventions, including speech therapy, in the same time period

Sponsors & Collaborators

• Paula Heikkinen: lead
• Hospital District of Helsinki and Uusimaa: collaborator
• Aalto University: collaborator
• Freie Universität Berlin: collaborator

Related Publications (1)

• Heikkinen PH, Pulvermuller F, Makela JP, Ilmoniemi RJ, Lioumis P, Kujala T, Manninen RL, Ahvenainen A, Klippi A. Combining rTMS With Intensive Language-Action Therapy in Chronic Aphasia: A Randomized Controlled Trial. Front Neurosci. 2019 Feb 4;12:1036. doi: 10.3389/fnins.2018.01036. eCollection 2018.

  PMID: 30778280 DERIVED

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anu Klippi, Professor

  University of Helsinki

  PRINCIPAL INVESTIGATOR

• Jyrki Mäkelä, MD

  BioMag Laboratory, Helsinki University Hospital

  STUDY CHAIR

• Friedemann Pulvermüller, Professor

  Brain Language Laboratory, Department of Philosophy and Humanities, WE4, Freie Universität Berlin

  STUDY CHAIR

• Risto Ilmoniemi, Professor

  Department of Neuroscience and Biomedical Engineering, Aalto University School of Science

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctoral student

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 14, 2018
• Study Start: January 2, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share