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
About this trial
This is an interventional treatment trial for Aphasia focused on measuring chronic aphasia, rehabilitation, randomized controlled trial (RCT)
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
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
NCT ID
NCT03629665
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
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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