Combining Language Therapy With rTMS in Aphasia (ILAT+rTMS)

Combining Language Therapy With rTMS in Chronic Stage of Aphasia: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Aphasia
• Intervention / Treatment: Behavioral: Intensive Language-Action Therapy (ILAT); Device: Repetitive navigated Transcranial Magnetic Stimulation during naming training

Detailed Description

New neuromodulation technologies, such as transcranial magnetic stimulation (TMS), are promising tools for neurorehabilitation, aphasia therapy included. Combined with behavioral techniques, Intensive Language-Action Therapy (ILAT), TMS could substantially amplify the beneficial effect of such behavioral therapy alone.

In this randomized study of 17 subjects with post-stroke aphasia in the chronic stage will be studied the combined effect of ILAT and 1-Hz placebo-controlled navigated repetitive TMS (rTMS) to the right-hemispheric inferior frontal cortex (pars triangularis). Participant will be randomized to groups A and B. Participants in group A will receive a 2-week period of rTMS during naming training where they name pictures every ten second displayed on the screen, followed by 2-weeks of rTMS and naming combined with ILAT. Those in group B will receive the same behavioral therapy but TMS is replaced by sham stimulation.

Language performance will be measured before, during and after the interventions for 3 months.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: rTMS and naming combined with ILAT; Interventions: Repetitive navigated Transcranial Magnetic Stimulation, picture naming and Intensive Language Action Therapy	Behavioral: Intensive Language-Action Therapy (ILAT); 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.; Device: Repetitive navigated Transcranial Magnetic Stimulation during naming training; 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.
Sham Comparator: sham rTMS and naming combined with ILAT; Interventions: sham Repetitive navigated Transcranial Magnetic Stimulation, picture naming and Intensive Language Action Therapy	Behavioral: Intensive Language-Action Therapy (ILAT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Boston naming test	picture naming ability	Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion
The Action naming test	picture naming ability	Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion

Collaborators and Investigators

• Sponsor: Paula Heikkinen
• Collaborators: Freie Universität Berlin; Aalto University; Hospital District of Helsinki and Uusimaa
• Investigators: Principal Investigator: Anu Klippi, Professor, University of Helsinki; Study Chair: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 12, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 12, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: rehabilitation; randomized controlled trial (RCT); chronic aphasia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: HelsinkiUniversity/Logopedics

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No