Combining Language Therapy With rTMS in Aphasia

NCT ID: NCT03629665

Last Updated: 2018-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-02
• Study Completion Date: 2014-03-01

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.

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.

Conditions

Aphasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

rTMS and naming combined with ILAT

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

Group Type: ACTIVE_COMPARATOR

Intensive Language-Action Therapy (ILAT)

Intervention Type: 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.

Repetitive navigated Transcranial Magnetic Stimulation during naming training

Intervention Type: 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.

sham rTMS and naming combined with ILAT

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

Group Type: SHAM_COMPARATOR

Intensive Language-Action Therapy (ILAT)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital District of Helsinki and Uusimaa

OTHER

Sponsor Role: collaborator

Aalto University

OTHER

Sponsor Role: collaborator

Freie Universität Berlin

OTHER

Sponsor Role: collaborator

Paula Heikkinen

OTHER

Sponsor Role: lead

Responsible Party

Paula Heikkinen

Doctoral student

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anu Klippi, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Jyrki Mäkelä, MD

Role: STUDY_CHAIR

BioMag Laboratory, Helsinki University Hospital

Friedemann Pulvermüller, Professor

Role: STUDY_CHAIR

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

Risto Ilmoniemi, Professor

Role: STUDY_CHAIR

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

References

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.

Reference Type: DERIVED

PMID: 30778280 (View on PubMed)

Other Identifiers

HelsinkiUniversity/Logopedics

Identifier Type: -

Identifier Source: org_study_id