Clinical trial NCT03629665: Combining Language Therapy With rTMS in Aphasia
Official title: Combining Language Therapy With rTMS in Chronic Stage of Aphasia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Keywords: chronic aphasia
rehabilitation
randomized controlled trial (RCT)
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Hospital District of Helsinki and Uusimaa
name: Aalto University
name: Freie Universität Berlin
First posted: 2018-08-14
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Western Aphasia Battery
timeFrame: Change in AQ performed at weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion
Secondary outcomes:
measure: The Boston naming test
timeFrame: Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion
measure: The Action naming test
timeFrame: Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion
Other outcomes:
Locations:
Study officials:
affiliation: University of Helsinki
name: Anu Klippi, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: BioMag Laboratory, Helsinki University Hospital
name: Jyrki Mäkelä, MD
role: STUDY_CHAIR
affiliation: Brain Language Laboratory, Department of Philosophy and Humanities, WE4, Freie Universität Berlin
name: Friedemann Pulvermüller, Professor
role: STUDY_CHAIR
affiliation: Department of Neuroscience and Biomedical Engineering, Aalto University School of Science
name: Risto Ilmoniemi, Professor
role: STUDY_CHAIR
References:
citation: 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.