AphasiaILAT+rTMSNCT03629665
Combining Language Therapy With rTMS in Aphasia
A study testing Intensive Language-Action Therapy (ILAT) and Repetitive navigated Transcranial Magnetic Stimulation during naming training in people with Aphasia, run by Paula Heikkinen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aphasia
- What is being tested?
- Intensive Language-Action Therapy (ILAT) and Repetitive navigated Transcranial Magnetic Stimulation during naming training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2012to 1 Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- availability of information about medication
- right-handedness
- native speakers of Finnish.
Who cannot join
- 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
About this study
Official title: Combining Language Therapy With rTMS in Chronic Stage of Aphasia: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Intensive Language-Action Therapy (ILAT), Repetitive navigated Transcranial Magnetic Stimulation during naming training
- Keywords
- chronic aphasia, rehabilitation, randomized controlled trial (RCT)
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Language-Action Therapy (ILAT)Behavioural
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 trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| rTMS and naming combined with ILAT | Active comparator | Interventions: Repetitive navigated Transcranial Magnetic Stimulation, picture naming and Intensive Language Action Therapy Receives: Behavioral: Intensive Language-Action Therapy (ILAT); Device: Repetitive navigated Transcranial Magnetic Stimulation during naming training |
| sham rTMS and naming combined with ILAT | Sham comparator | Interventions: sham Repetitive navigated Transcranial Magnetic Stimulation, picture naming and Intensive Language Action Therapy Receives: Behavioral: Intensive Language-Action Therapy (ILAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Aphasia Battery
aphasia quotient (AQ) measurement
Measured: Change in AQ performed at weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion
Secondary outcomes (2)
The Boston naming test
picture naming ability
Measured: Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion
The Action naming test
picture naming ability
Measured: Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start2 Jan 2012
- Primary completion1 Mar 2014
- Study completion1 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paula Heikkinen
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital District of Helsinki and Uusimaa, Aalto University, Freie Universität Berlin
- Responsible party
- Sponsor-investigator, Paula Heikkinen, University of Helsinki
- Investigators
- Anu Klippi, Professor, Principal investigator, University of HelsinkiJyrki Mäkelä, MD, Study chair, BioMag Laboratory, Helsinki University HospitalFriedemann Pulvermüller, Professor, Study chair, Brain Language Laboratory, Department of Philosophy and Humanities, WE4, Freie Universität BerlinRisto Ilmoniemi, Professor, Study chair, Department of Neuroscience and Biomedical Engineering, Aalto University School of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629665
- Sponsor's protocol ID
- HelsinkiUniversity/Logopedics
- Acronym
- ILAT+rTMS
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30778280
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Language Therapy With rTMS in Chronic Stage of Aphasia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03629665
- Acronym / sponsor ID
- ILAT+rTMS / HelsinkiUniversity/Logopedics
- Conditions
- Aphasia
- Keywords
- chronic aphasia, rehabilitation, randomized controlled trial (RCT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Paula HeikkinenUniversity, hospital or other
- Collaborators
- Hospital District of Helsinki and Uusimaa, Aalto University, Freie Universität Berlin
- Study start
- 2 Jan 2012 (actual)
- Primary completion
- 1 Mar 2014 (actual)
- Study completion
- 1 Mar 2014 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS and naming combined with ILAT | Active comparator | Behavioral: Intensive Language-Action Therapy (ILAT), Device: Repetitive navigated Transcranial Magnetic Stimulation during naming trainingInterventions: Repetitive navigated Transcranial Magnetic Stimulation, picture naming and Intensive Language Action Therapy |
| sham rTMS and naming combined with ILAT | Sham comparator | Behavioral: Intensive Language-Action Therapy (ILAT)Interventions: sham Repetitive navigated Transcranial Magnetic Stimulation, picture naming and Intensive Language Action Therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | rTMS and naming combined with ILAT, sham rTMS and naming combined with ILAT |
| Repetitive navigated Transcranial Magnetic Stimulation during naming trainingMagnetic 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. | Device | rTMS and naming combined with ILAT |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 30778280Heikkinen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anu Klippi, Professor principal investigator
University of Helsinki
Jyrki Mäkelä, MD study chair
BioMag Laboratory, Helsinki University Hospital
Friedemann Pulvermüller, Professor study chair
Brain Language Laboratory, Department of Philosophy and Humanities, WE4, Freie Universität Berlin
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Language-Action Therapy (ILAT) and Repetitive navigated Transcranial Magnetic Stimulation during naming training in people with Aphasia, run by Paula Heikkinen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03629665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.