Combining Language Therapy With rTMS in Aphasia

Aphasia Clinical Trial

— ILAT+rTMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629665
• Other study ID #: HelsinkiUniversity/Logopedics
• Status: Completed
• Phase: N/A
• Start date: January 2, 2012
• Est. completion date: March 1, 2014

Study information

• Verified date: August 2018
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 triangularis), thus taking advantage of recent research in speech and language sciences, neurorehabilitation and brain research.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 1, 2014
• Est. primary completion date: March 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia

Intervention

Behavioral:
• 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.

Device:
• Repetitive navigated Transcranial Magnetic Stimulation during naming training
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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Paula Heikkinen	Aalto University, Freie Universität Berlin, Hospital District of Helsinki and Uusimaa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Western Aphasia Battery	aphasia quotient (AQ) measurement	Change in AQ performed at weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion
Secondary	The Boston naming test	picture naming ability	Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion
Secondary	The Action naming test	picture naming ability	Change in picture naming ability between weeks 1 (baseline), 4 and 7 and follow up 3 months after therapy completion