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Completed

NCT Number: NCT03629665

Combining Language Therapy With rTMS in Aphasia

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. The Western Aphasia Battery

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

    aphasia quotient (AQ) measurement

Secondary outcomes

  1. The Boston naming test

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

    picture naming ability

  2. The Action naming test

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

    picture naming ability

Sponsors and collaborators

Lead sponsor

Paula Heikkinen

Other

Collaborators

  • Aalto University
  • Freie Universität Berlin
  • Hospital District of Helsinki and Uusimaa

Registry information

Official study title

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

Acronym: ILAT+rTMS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 14, 2018
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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