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

Primary Purpose

Aphasia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intensive Language-Action Therapy (ILAT)
Repetitive navigated Transcranial Magnetic Stimulation during naming training
Sponsored by
Paula Heikkinen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring chronic aphasia, rehabilitation, randomized controlled trial (RCT)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    rTMS and naming combined with ILAT

    sham rTMS and naming combined with ILAT

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    The Western Aphasia Battery
    aphasia quotient (AQ) measurement

    Secondary Outcome Measures

    The Boston naming test
    picture naming ability
    The Action naming test
    picture naming ability

    Full Information

    First Posted
    July 31, 2018
    Last Updated
    August 12, 2018
    Sponsor
    Paula Heikkinen
    Collaborators
    Hospital District of Helsinki and Uusimaa, Aalto University, Freie Universität Berlin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03629665
    Brief Title
    Combining Language Therapy With rTMS in Aphasia
    Acronym
    ILAT+rTMS
    Official Title
    Combining Language Therapy With rTMS in Chronic Stage of Aphasia: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2, 2012 (Actual)
    Primary Completion Date
    March 1, 2014 (Actual)
    Study Completion Date
    March 1, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Paula Heikkinen
    Collaborators
    Hospital District of Helsinki and Uusimaa, Aalto University, Freie Universität Berlin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aphasia
    Keywords
    chronic aphasia, rehabilitation, randomized controlled trial (RCT)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    rTMS and naming combined with ILAT
    Arm Type
    Active Comparator
    Arm Description
    Interventions: Repetitive navigated Transcranial Magnetic Stimulation, picture naming and Intensive Language Action Therapy
    Arm Title
    sham rTMS and naming combined with ILAT
    Arm Type
    Sham Comparator
    Arm Description
    Interventions: sham Repetitive navigated Transcranial Magnetic Stimulation, picture naming and Intensive Language Action Therapy
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intensive Language-Action Therapy (ILAT)
    Intervention Description
    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
    Device
    Intervention Name(s)
    Repetitive navigated Transcranial Magnetic Stimulation during naming training
    Intervention Description
    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 Outcome Measure Information:
    Title
    The Western Aphasia Battery
    Description
    aphasia quotient (AQ) measurement
    Time Frame
    Change in AQ performed at weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion
    Secondary Outcome Measure Information:
    Title
    The Boston naming test
    Description
    picture naming ability
    Time Frame
    Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion
    Title
    The Action naming test
    Description
    picture naming ability
    Time Frame
    Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anu Klippi, Professor
    Organizational Affiliation
    University of Helsinki
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jyrki Mäkelä, MD
    Organizational Affiliation
    BioMag Laboratory, Helsinki University Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Friedemann Pulvermüller, Professor
    Organizational Affiliation
    Brain Language Laboratory, Department of Philosophy and Humanities, WE4, Freie Universität Berlin
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Risto Ilmoniemi, Professor
    Organizational Affiliation
    Department of Neuroscience and Biomedical Engineering, Aalto University School of Science
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30778280
    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.
    Results Reference
    derived

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    Combining Language Therapy With rTMS in Aphasia

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