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Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia

Primary Purpose

Stroke, Ischemic, Aphasia Non Fluent

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Noninvasive transcranial brain stimulation: excitatory iTBS
Noninvasive transcranial brain stimulation: inhibitory cTBS
Individual speech-language therapy (SLT)
Sham TBS simulating left hemispheric iTBS
Sponsored by
Institute of Psychiatry and Neurology, Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Aphasia, Stroke, Theta Burst Stimulation, Therapy, Rehabilitation, Noninvasive Transcranial Brain Stimulation

Eligibility Criteria

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

Inclusion Criteria:

  • First-ever left middle cerebral artery ischemic stroke (brain damage localization confirmed by magnetic resonance imaging, MRI)
  • 3 or more months from the onset of stroke
  • Non-fluent aphasia (confirmed in the BDAE test) with functional communication difficulties ranging from mild to significant (grades from 2 to 4 in ASRS), marked difficulties in naming, and relatively preserved everyday speech comprehension
  • Native Polish speaker
  • Right-handedness prior to stroke
  • Signing of the informed consent for the participation in the study.

Exclusion Criteria:

  • Psychiatric and/or neurological comorbidity (e. g. dementia, depressive disorder, alcohol dependence)
  • Diagnose of epilepsy or epileptic changes in EEG, also frequent losses of consciousness of unclear etiology which might suggest epileptic seizures
  • History of any neurosurgical procedure around the head area
  • 1.5 T MRI examination contraindications (metal elements in the body, e. g. implantable cardioverter-defibrillator, deep brain stimulation devices; claustrophobia)
  • Regular intake of medication that could affect cortical excitability (e. g. antiepileptic or antipsychotic drugs, antidepressants, benzodiazepines) or medication influencing neuroplastic processes (e. g. dopamine)
  • Significant cognitive impairment limiting patient's cooperation during assessment and behavioral aphasia therapy
  • Visual deficits significantly hindering the perception of therapeutic tasks presented visually on a computer's screen
  • New neurological episode (e. g. another brain stroke) or somatic illness (e. g. COVID-19) during the cycle of the therapy, requiring its interruption.

Sites / Locations

  • Institute of Psychiatry and NeurologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Intermittent TBS (iTBS) of the left hemisphere plus behavioral aphasia therapy

Continuous TBS (cTBS) of the right hemisphere plus behavioral aphasia therapy

Sham TBS (sTBS) of the left hemisphere plus behavioral aphasia therapy

Arm Description

15 sessions of 200-second of iTBS over the pars triangularis of Broca's area in the left hemisphere (BA 45), preceding 45-minutes of behavioral aphasia therapy.

15 sessions of 40 seconds of cTBS over the pars triangularis of the right inferior frontal gyrus (BA 45 homologue), preceding 45-minutes of behavioral aphasia therapy.

15 sessions of sham TBS over the pars triangularis of Broca's area in the left hemisphere (BA 45), preceding 45-minutes of behavioral aphasia therapy.

Outcomes

Primary Outcome Measures

Change from pre-treatment assessment in the performance on a picture naming task
Total number of correctly named items (assessed: accuracy and speed of naming) from a set of 250 visually presented objects (200 noun names and 50 verb names; stimuli included in the set are diversified with regard to the articulation difficulty of corresponding words and their usage frequency in everyday speech).
Change from pre-treatment in the performance on the picture naming task at 3 months post-therapy (follow up assessment)
Total number of correctly named items from a set of 250 visually presented objects.
Change from post-treatment in the performance on the picture naming task at 3 months post-therapy
Total number of correctly named items from a set of 250 visually presented objects.
Change from pre-treatment assessment in the performance on a scene description task of three visually presented scenes
(assessed: length and correctness of utterances).
Change from pre-treatment in the scene description task at 3 months post-therapy
Oral description of three visually presented scenes (assessed: length and correctness of utterances).
Change from post-treatment in the scene description task at 3 months post-therapy
Oral description of three visually presented scenes (assessed: length and correctness of utterances).
Change from pre-treatment on the semantic fluency task
Producing within a minute as many words as possible from 3 semantic categories: animals, fruit, clothes; assessed: total number of correctly generated items.
Change from pre-treatment on the semantic fluency task at 3 months post-therapy
Total number of correctly generated items such as animals, fruits, clothes.
Change from post-treatment on the semantic fluency task at 3 months post-therapy
Total number of correctly generated items such as animals, fruits, clothes.

Secondary Outcome Measures

Modified Communication Effectiveness Index (CETI)
A questionnaire to complete by researcher and family member/caregiver. Contains descriptions of ten communication situations, patients' performance in each of them is assessed on a Likert-type scale (from 0 to 7). Higher score means better functional communication.

Full Information

First Posted
March 22, 2022
Last Updated
September 27, 2023
Sponsor
Institute of Psychiatry and Neurology, Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT05303649
Brief Title
Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia
Official Title
Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Psychiatry and Neurology, Warsaw

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
Aphasia is an impairment in the ability to express and/or understand language, commonly observed after stroke to the language dominant (left) hemisphere. Despite natural tendency to spontaneous functional recovery in the first months post stroke and language improvement due to application of behavioral speech and language therapy (SLT), many aphasic patients do not achieve satisfactory level of verbal communication. The aim of the planned study is to explore the potential of the noninvasive repetitive Transcranial Magnetic Stimulation (rTMS) as a therapeutic tool for aphasia in addition to traditional behavioral therapy. In case of aphasia, studies on therapeutic effectiveness of rTMS aim to increase the activity of the language-dominant left cerebral hemisphere, which may be achieved in an indirect manner by inhibiting the activity of the opposite (right) hemisphere or in a direct manner by increasing the excitability of preserved language areas in the left hemisphere. In our study, we plan to administer the newest form of rTMS called Theta Burst Stimulation (TBS), which is safer than the conventional rTMS, even when used in the perilesional area. Computer-based neuronavigation system will be implemented to precisely localize stimulation targets, control administration of stimuli during rTMS sessions, and evaluate differences between participants regarding deviations from established stimulation points. 45 patients (all right-handed, polish native speakers, aged 18-75 years, diagnosed with non-fluent aphasia) will be enrolled in a randomized, double-blind, sham-controlled trial. Subjects will be randomly assigned to one of the three groups: 1) a group with excitatory intermittent TBS of the left hemisphere (iTBS group), 2) a group with inhibitory continuous TBS of the right hemisphere (cTBS group), 3) a group with sham TBS (sTBS group as a control group). Specific forms of stimulation will be carried out for three consecutive weeks (Monday to Friday; a total of 15 stimulation sessions). Immediately after each session of the stimulation, patients will undergo individual SLT. Assessment of language functioning will be carried out three times: before and after the therapy period, and 3 months after its completion. Results of the study will broaden knowledge about hemispherical mechanisms of language and speech recovery after stroke and provide insight into possibilities of their modulation for the purpose of post-stroke rehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Aphasia Non Fluent
Keywords
Aphasia, Stroke, Theta Burst Stimulation, Therapy, Rehabilitation, Noninvasive Transcranial Brain Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermittent TBS (iTBS) of the left hemisphere plus behavioral aphasia therapy
Arm Type
Experimental
Arm Description
15 sessions of 200-second of iTBS over the pars triangularis of Broca's area in the left hemisphere (BA 45), preceding 45-minutes of behavioral aphasia therapy.
Arm Title
Continuous TBS (cTBS) of the right hemisphere plus behavioral aphasia therapy
Arm Type
Experimental
Arm Description
15 sessions of 40 seconds of cTBS over the pars triangularis of the right inferior frontal gyrus (BA 45 homologue), preceding 45-minutes of behavioral aphasia therapy.
Arm Title
Sham TBS (sTBS) of the left hemisphere plus behavioral aphasia therapy
Arm Type
Sham Comparator
Arm Description
15 sessions of sham TBS over the pars triangularis of Broca's area in the left hemisphere (BA 45), preceding 45-minutes of behavioral aphasia therapy.
Intervention Type
Device
Intervention Name(s)
Noninvasive transcranial brain stimulation: excitatory iTBS
Other Intervention Name(s)
Magstim Super Rapid2
Intervention Description
600 pulses (3 pulses at 50 Hz given every 200 milliseconds in 2-second trains at 10-second intervals, delivered at 80% of active motor threshold) generated by Magstim Super Rapid2 stimulator equipped with a figure-of-eight coil applied over BA 45 Device: Magstim Co., Wales, UK.
Intervention Type
Device
Intervention Name(s)
Noninvasive transcranial brain stimulation: inhibitory cTBS
Other Intervention Name(s)
Magstim Super Rapid2
Intervention Description
600 pulses (3 pulses at 50 Hz, repeated at 5 Hz, delivered at 80% of active motor threshold) generated by Magstim Super Rapid2 stimulator equipped with a figure-of-eight coil applied over BA 45 homologue Device: Magstim Co., Wales, UK.
Intervention Type
Behavioral
Intervention Name(s)
Individual speech-language therapy (SLT)
Intervention Description
45 minutes training tailored to every patient's deficits, abilities and needs. Exercises used during each therapeutic session include: expressions tasks (naming and sentence building), complex utterances comprehension tasks, reading and writing exercises. Training is administered using paper-and-pencil tasks and computerized aphasia therapy program AfaSystem (Harpo sp.zoo, Poznań, Poland).
Intervention Type
Device
Intervention Name(s)
Sham TBS simulating left hemispheric iTBS
Other Intervention Name(s)
Magstim Super Rapid2
Intervention Description
Sham TMS coil positioned exactly like an active TMS coil resulting in a very good approximation of the auditory effects Device: Magstim Co., Wales, UK.
Primary Outcome Measure Information:
Title
Change from pre-treatment assessment in the performance on a picture naming task
Description
Total number of correctly named items (assessed: accuracy and speed of naming) from a set of 250 visually presented objects (200 noun names and 50 verb names; stimuli included in the set are diversified with regard to the articulation difficulty of corresponding words and their usage frequency in everyday speech).
Time Frame
Pre-treatment assessment (within 2 days before starting the intervention), post-treatment assessment (within 2 days of completing the 15 days intervention)
Title
Change from pre-treatment in the performance on the picture naming task at 3 months post-therapy (follow up assessment)
Description
Total number of correctly named items from a set of 250 visually presented objects.
Time Frame
Pre-treatment and 3 months follow-up (post-treatment) assessment
Title
Change from post-treatment in the performance on the picture naming task at 3 months post-therapy
Description
Total number of correctly named items from a set of 250 visually presented objects.
Time Frame
Post-treatment and 3 months follow-up assessment
Title
Change from pre-treatment assessment in the performance on a scene description task of three visually presented scenes
Description
(assessed: length and correctness of utterances).
Time Frame
Pre-treatment assessment, post-treatment assessment (within 2 days of completing the 15 days intervention)
Title
Change from pre-treatment in the scene description task at 3 months post-therapy
Description
Oral description of three visually presented scenes (assessed: length and correctness of utterances).
Time Frame
Pre-treatment and 3 months follow-up
Title
Change from post-treatment in the scene description task at 3 months post-therapy
Description
Oral description of three visually presented scenes (assessed: length and correctness of utterances).
Time Frame
Post-treatment and 3 months follow-up
Title
Change from pre-treatment on the semantic fluency task
Description
Producing within a minute as many words as possible from 3 semantic categories: animals, fruit, clothes; assessed: total number of correctly generated items.
Time Frame
Pre-treatment and post-treatment (within 2 days of completing the 15 days intervention)
Title
Change from pre-treatment on the semantic fluency task at 3 months post-therapy
Description
Total number of correctly generated items such as animals, fruits, clothes.
Time Frame
Pre-treatment and 3 months follow-up
Title
Change from post-treatment on the semantic fluency task at 3 months post-therapy
Description
Total number of correctly generated items such as animals, fruits, clothes.
Time Frame
Post-treatment and 3 months follow-up
Secondary Outcome Measure Information:
Title
Modified Communication Effectiveness Index (CETI)
Description
A questionnaire to complete by researcher and family member/caregiver. Contains descriptions of ten communication situations, patients' performance in each of them is assessed on a Likert-type scale (from 0 to 7). Higher score means better functional communication.
Time Frame
Pre-treatment, post-treatment (within 2 days of completing the 15 day intervention) and on 3-month follow-up
Other Pre-specified Outcome Measures:
Title
The Polish version of short form of the Boston Diagnostic Aphasia Examination (BDAE)
Description
Assesses the linguistic skills of adults with aphasia. This provides information for the diagnosis of the type of aphasia. Includes the six-point Goodglass and Kaplan's Aphasia Severity Rating Scale (ASRS; 0-5 points - lower score means more severe language impairment).
Time Frame
Screening appointment (pre-enrollment assessment)

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: First-ever left middle cerebral artery ischemic stroke (brain damage localization confirmed by magnetic resonance imaging, MRI) 3 or more months from the onset of stroke Non-fluent aphasia (confirmed in the BDAE test) with functional communication difficulties ranging from mild to significant (grades from 2 to 4 in ASRS), marked difficulties in naming, and relatively preserved everyday speech comprehension Native Polish speaker Right-handedness prior to stroke Signing of the informed consent for the participation in the study. Exclusion Criteria: Psychiatric and/or neurological comorbidity (e. g. dementia, depressive disorder, alcohol dependence) Diagnose of epilepsy or epileptic changes in EEG, also frequent losses of consciousness of unclear etiology which might suggest epileptic seizures History of any neurosurgical procedure around the head area 1.5 T MRI examination contraindications (metal elements in the body, e. g. implantable cardioverter-defibrillator, deep brain stimulation devices; claustrophobia) Regular intake of medication that could affect cortical excitability (e. g. antiepileptic or antipsychotic drugs, antidepressants, benzodiazepines) or medication influencing neuroplastic processes (e. g. dopamine) Significant cognitive impairment limiting patient's cooperation during assessment and behavioral aphasia therapy Visual deficits significantly hindering the perception of therapeutic tasks presented visually on a computer's screen New neurological episode (e. g. another brain stroke) or somatic illness (e. g. COVID-19) during the cycle of the therapy, requiring its interruption.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna E Polanowska, PhD
Phone
+48224582870
Email
kpolanowska@ipin.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Szczepan Iwański, PhD
Phone
+48224582870
Email
iwanski@ipin.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarzyna E Polanowska, PhD
Organizational Affiliation
Institute of Psychiatry and Neurology, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Psychiatry and Neurology
City
Warsaw
State/Province
Masovian Voivodeship
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna E Polanowska, PhD
Phone
+48224582870
Email
kpolanowska@ipin.edu.pl

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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30870740
Citation
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Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia

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