Recovery From Post-Stroke Aphasia With rTMS Targeting Left or Right Anterior Temporal Lobe (ATLAS)
Recovery From Post-Stroke Aphasia With rTMS Targeting the Anterior Temporal Lobe: Interhemispheric Activation Changes and Lesion-Connectome-Based Predictive Outcomes
調査の概要
状態
詳細な説明
Background and aims In the United States, 18 to 66% of individuals who experience a stroke will suffer from language impairment, referred to as aphasia. Aphasia profoundly impacts quality of life by restricting participation in social, familial, and professional spheres. While the gold standard for aphasia rehabilitation is Speech and Language Therapy (SLT), it often does not lead to complete recovery. Repetitive Transcranial Magnetic Stimulation (rTMS) or Transcranial Direct Current Stimulation (tDCS) are non-invasive brain stimulation techniques that could enhance post-stroke aphasia recovery. Most rTMS and tDCS studies in post-stroke aphasia following left hemispheric strokes have applied inhibitory stimulation targeting the right Inferior Frontal Gyrus (IFG) or facilitatory stimulation targeting the left IFG (i.e., Broca's area and its right homologue).
Aim 1: Focusing solely on the IFG for all participants with post-stroke aphasia may be inefficient, as the language system is widespread and complex, and involves large, interconnected networks also linked to non-linguistic cognitive functions such as working memory or executive functions. Previous research indicated that individuals with different language impairments may have varied recovery paths, and using the same cortical target for non-invasive brain stimulation might be ineffective or even impair recovery. Interestingly, rTMS targeting the motor cortex of the lips in people with phonological impairments improved accuracy and decreased phonological errors in a Picture Naming Task. This improvement likely resulted from rTMS modulating not only the targeted motor cortex but also the connected dorsal phonological stream via intra- and interhemispheric connections. Building on this principle, a pilot study was conducted using inhibitory rTMS targeting the right Anterior Temporal Lobe (ATL) in people with post-stroke aphasia suffering from lexicosemantic impairments, with improvement in Picture Naming for all participants. Lexicosemantic difficulties manifest as anomia and/or semantic errors (e.g., saying tea instead of coffee) and can result from deficits in lexical access or within the semantic system itself. Lexicosemantic processes involve a complex brain network. According to the hub-and-spokes theory, the ATL serves as a central amodal semantic hub that integrates information from various modalities. Other theories emphasize its multimodal and potentially lexical sensibility. This study hypothesizes that rTMS targeting the ATL will modulate the ventral stream of language, resulting in improvements in people with lexicosemantic impairments. This RCT aims to combine ATL stimulation with Semantic Feature Analysis (SFA) rehabilitation, which strengthens lexicosemantic links. This approach was expected to enhance the effect of rTMS on lexicosemantic processes.
Aim 2 and 3.3: Furthermore, the facilitation of the left hemisphere and the inhibition of the right undamaged hemisphere are based on the theory of transcallosal interhemispheric imbalance, where brain lesion leads to hyperactivation of the undamaged hemisphere and hypoactivation of the damaged hemisphere. The undamaged right hemisphere could play a maladaptive role in post-stroke aphasia recovery. However, the role of right hemisphere activation in post-stroke aphasia recovery remains unclear, as it may support recovery in certain participants during both the subacute and chronic phases. More research is needed to better understand the underlying mechanisms of facilitatory and inhibitory stimulation targeting respectively the undamaged and damaged hemispheres.
Aim 3: While non-invasive brain stimulation has been shown to be effective in post-stroke aphasia, certain people with post-stroke aphasia respond better than others. The previous sections highlighted the impact cortical target and stimulation parameters, but recent studies have also proposed that participant's aphasia type or lesion localization may influence their response. Further research, particularly using rTMS, is needed to clarify how lesion localization and disconnections contribute to recovery, as these factors may explain chronic post-stroke language impairments and predict rTMS efficacy. Since the ATL serves as a central hub in the ventral lexicosemantic stream, and rTMS modulates other brain areas through both inter- and intra-hemispheric connectivity, the hypothesis was as follow: a preserved connectivity between the ATL and the posterior temporal lobe will be a strong predictor of rTMS effectiveness.
Study Intervention Participants will be randomly assigned to one of three groups: (1) the inhibitory continuous Theta Burst Stimulation (cTBS) targeting the right ATL, (2) the facilitatory intermittent Theta Burst Stimulation (iTBS) targeting the left ATL, or (3) the sham control TMS group, with sham stimulation targeting either the left or right ATL in half of the participants. The intervention will consist of two weeks of stimulation according to group assignment, five times per week (10 sessions total), followed by 30 minutes of Speech-Language Therapy using the Semantic Feature Analysis method.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sophie Arheix-Parras, PhD
- 電話番号：803-467-8018
- メール：sophie.arheix-parras@sc.edu
研究場所
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South Carolina
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Columbia、South Carolina、アメリカ、29203
- 募集
- McCausland Center
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コンタクト：
- Makayla Gibson, PhD
- 電話番号：803-777-0169
- メール：mjgibson@email.sc.edu
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主任研究者：
- Sophie Arheix-Parras, PhD
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副調査官：
- Chris Rorden, PhD
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副調査官：
- Rutvik H Desai, PhD
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副調査官：
- Leonardo Bonilha, PhD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Right-handedness (assesed using the Edinburgh Handedness Inventory)
- Native English speakers
- Single left hemispheric stroke
- Diagnosis of aphasia and lexicosemantic impairments (e.g., anomia, semantic errors in picture naming or spontaneous speech) confirmed by a Speech and Language Pathologist or Physician
Exclusion Criteria:
- Severely impaired auditory comprehension (WAB Comprehension score of 0 or 1)
- Major phonological impairments (defined as > 2 errors in non-word repetition of one- and two-syllable items on the PALPA, 2)
- Contraindications to rTMS (e.g., uncontrolled epilepsy, history of seizures, intracranial ferromagnetic body, cochlear implant, or factors that lower seizure threshold (see Rossi et al., 2021)
- Contraindication to MRI
- Stroke involving the left ATL
- Severe depression or psychiatric history
- Illiteracy
- Known neurodegenerative disorders
- Severe uncorrected visual or hearing impairments
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Inhibitory rTMS
Participants will receive inhibitory continuous Theta Burst Stimulation (cTBS) targeting the right ATL 5 times a week for 2 weeks.
Each stimulation session will be followed by 30-min of Speech and Language Therapy using the Semantic Feature Analysis protocol.
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We will use continuous Theta Burst Stimulation (600 pulses, burst frequency at 5 Hz, burst of three pulses at 50Hz) targeting the right ATL
他の名前：
Participants will receive 30 minutes of Semantic Feature Analysis therapy administered by a Speech and Language Pathologist.
On a computer screen, participants will see an image of an object and will be cued to retrieve the object's name by describing various features of the object, including its physical properties, typical location, personal associations, category, use and actions involving the object (Quique et al., 2019).
他の名前：
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実験的：Facilitatory rTMS
Participants will receive facilitatory intermittent Theta Burst Stimulation (iTBS) targeting the left ATL 5 times a week for 2 weeks.
Each stimulation session will be followed by 30-min of Speech and Language Therapy using the Semantic Feature Analysis protocol.
|
Participants will receive 30 minutes of Semantic Feature Analysis therapy administered by a Speech and Language Pathologist.
On a computer screen, participants will see an image of an object and will be cued to retrieve the object's name by describing various features of the object, including its physical properties, typical location, personal associations, category, use and actions involving the object (Quique et al., 2019).
他の名前：
We will use intermittent Theta Burst Stimulation (600 pulses, burst frequency at 5 Hz, burst of three pulses at 50Hz, interval intertrain of 8 sec, 10 pulses in train) targeting the left ATL
他の名前：
|
|
偽コンパレータ：Sham rTMS
Participants will receive sham stimulation targeting either the left or right ATL with allocation balanced across participants, 5 times a week for 2 weeks.
Each stimulation session will be followed by 30-min of Speech and Language Therapy using the Semantic Feature Analysis protocol.
|
Participants will receive 30 minutes of Semantic Feature Analysis therapy administered by a Speech and Language Pathologist.
On a computer screen, participants will see an image of an object and will be cued to retrieve the object's name by describing various features of the object, including its physical properties, typical location, personal associations, category, use and actions involving the object (Quique et al., 2019).
他の名前：
We will use sham stimulation using the same coil but flipped over, with the left ATL targeted in half of the participant and the right ATL in the other half.
The placebo coil will replicate the auditory sensations produced by active stimulation.
In addition, we will use electrical stimulation of the scalp (via electrodes placed over specific muscles) in the Sham group to mimic the sensory effects of active stimulation.
Participants will have no prior rTMS experience before inclusion in the protocol.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Picture Naming task accuracy
時間枠：Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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The primary outcome is improvement in accuracy of the a Picture Naming task.
Participants will complete a Picture Naming tasks based on the Older Adult Naming Test.
Participants will name items from pictures as quickly and accurately as possible.
Items will include mid-frequency words and 10 pictures of middle-to-late age-of-acquisition words (mean = 10.01 years, SD = 1.16).
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Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Picture Naming Reaction time
時間枠：Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Reaction times will also be recorded for the picture naming task using E-Prime software (version 3.0).
A decrease in reaction time for the picture naming task will be considered as an improvement.
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Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Auditory Description Naming accuracy
時間枠：Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Participants will complete an Auditory Description Naming based on the Older Adult Naming Test.
Participants will name items from verbal descriptions as quickly and accurately as possible.
Items will include mid-frequency words supplemented with 10 descriptions of middle to high-frequency abstract words (mean frequency = 3.45, SD = 0.90).
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Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Auditory Description Naming reaction time
時間枠：Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
|
Reaction times will also be recorded using E-Prime software (version 3.0) for the auditory description naming task.
A decrease in Reaction Time will be considered as improvement.
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Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
|
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Comprehensive Aphasia Test - aphasia impact questionnaire
時間枠：Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Online version of the Comprehensive Aphasia Test (CAT): Aphasia Impact Questionnaire score (124-item scale; higher scores indicate a greater impact of aphasia on the participant's life, meaning worse outcome).
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Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Similarity task Accuracy
時間枠：Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Participants will be asked whether pairs of items are similar or dissimilar in meaning (for example, coffee and tea are similar in meaning, whereas cat and cup are not).
Accuracy will be recorded.
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Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Similarity task - reaction time
時間枠：Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
|
We will also measure Reaction time for this task.
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Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Verb naming task accuracy
時間枠：Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Verb naming will be assessed using video clips from the T-DAV 20.
Only the number of correct answers will be recorded as an outcome measure.
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Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Digit span
時間枠：Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Digit span (WAIS-IV) for the working memory and the total score will be reported.
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Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Flanker task
時間枠：Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
|
Using an E-Prime script, inhibitory processes will be measured with the Flanker task.
Accuracy will be used as the outcome measure.
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Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Flexibility - Trail Making Test
時間枠：Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Flexibility will be measured using the Trail Making Test, and the reaction time difference between Parts B and A will be used as the outcome measure.
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Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Comprehensive Aphasia Test - cognitive screening
時間枠：Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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Online version of the Comprehensive Aphasia Test (CAT): cognitive screening score (scale /49, higher meaning better outcome)
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Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
|
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Comprehensive Aphasia Test - language score
時間枠：Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
|
Online version of the Comprehensive Aphasia Test (CAT): language comprehension (spoken and written words, sentences, and paragraphs) and expressive language (repetition, picture description, reading aloud, writing) (Total scale /402, higher meaning better outcome).
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Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Hilari K, Byng S, Lamping DL, Smith SC. Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39): evaluation of acceptability, reliability, and validity. Stroke. 2003 Aug;34(8):1944-50. doi: 10.1161/01.STR.0000081987.46660.ED. Epub 2003 Jul 10.
- Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.
- Quique YM, Evans WS, Dickey MW. Acquisition and Generalization Responses in Aphasia Naming Treatment: A Meta-Analysis of Semantic Feature Analysis Outcomes. Am J Speech Lang Pathol. 2019 Mar 11;28(1S):230-246. doi: 10.1044/2018_AJSLP-17-0155.
- Arheix-Parras S, Barrios C, Python G, Cogne M, Sibon I, Engelhardt M, Dehail P, Cassoudesalle H, Moucheboeuf G, Glize B. A systematic review of repetitive transcranial magnetic stimulation in aphasia rehabilitation: Leads for future studies. Neurosci Biobehav Rev. 2021 Aug;127:212-241. doi: 10.1016/j.neubiorev.2021.04.008. Epub 2021 Apr 20.
- Nippold MA, Mansfield TC, Billow JL. Peer conflict explanations in children, adolescents, and adults: examining the development of complex syntax. Am J Speech Lang Pathol. 2007 May;16(2):179-88. doi: 10.1044/1058-0360(2007/022).
- Arheix-Parras S, Moore SR, Desai RH. Improving Lexicosemantic Impairments in Post-Stroke Aphasia Using rTMS Targeting the Right Anterior Temporal Lobe. Brain Sci. 2026 Jan 22;16(1):117. doi: 10.3390/brainsci16010117.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00000481
- K99DC023302 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The expected data types include:
- Behavioral data: Accuracy and reaction times measures for cognitive and language tasks.
- Neuroimaging data: Structural MRI (T1 and T2 weighted) and functional MRI (resting state and task-based, for around 15 minutes per session)
IPD 共有時間枠
IPD 共有アクセス基準
Interested research will be able to access the following data : - De-identified behavioral data (reaction time, accuracy, transcription) at be shared publicly using OSF
- Audio recordings will not be shared due to confidentiality risks
- Neuroimaging data (structural and functional MRI) will be shared after de-identification (face removal) in OpenNeuro
- Aggregate results will be disseminated via peer-reviewed publications and conference presentations.
- Study protocol, task descriptions, and analysis pipelines will be documented in manuscripts
- Metadata describing participant demographics (e.g., age, gender, stroke type, lesion location) will be included in shared dataset and available in manuscripts
- Documentation will be provided upon request to facilitate data interpretation
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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