Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
A Study of Transcranial Electrical Stimulation (tES) Paired With Structured Learning Protocols for Accelerated Skill Acquisition: Sub-Protocol B (Pediatric Reading Support for Children With Dyslexia and Reading Disabilities)
This study investigates whether transcranial electrical stimulation (tES) delivered during structured reading instruction affects reading proficiency in children with developmental dyslexia and related reading disabilities.
Children aged 7 to 17 who have been identified as having dyslexia or reading difficulties are randomly assigned in equal numbers to receive either active stimulation or sham (placebo) stimulation while completing structured reading instruction. Participants wear a non-invasive transcranial electrical stimulation headset that delivers a low-level electrical current through electrodes resting on the scalp. Sessions typically last 20 to 30 minutes and may take place at home or in person at a participating site. A trained adult is present and supervising for every session.
Reading proficiency is measured with standardized assessments before and after the intervention period. A follow-up assessment may be conducted up to 12 months after the intervention ends.
The device used in this study is investigational and has not been approved or cleared by the U.S. Food and Drug Administration.
調査の概要
状態
詳細な説明
Regulatory pathway: because developmental dyslexia and related learning disabilities are considered diseases by the U.S. Food and Drug Administration for purposes of device classification, the investigational use of tES in this study falls within FDA jurisdiction. The study is conducted under the abbreviated investigational device exemption pathway on the basis of an IRB non-significant risk determination under 21 CFR 812.2(b). No IDE number is issued by FDA for a study conducted under this pathway.
The study is a prospective, randomized, double-blind, sham-controlled investigation. Participants are randomized 1:1 to active or sham stimulation, with stratification by site or cohort as applicable. Neither participants nor the research team conducting outcome assessments are aware of assignment during data collection. Stimulation assignment is held by the Sub-Investigator and is not disclosed to the Principal Investigator until all outcome data are collected and locked and primary analyses are finalized.
Sessions may be delivered by decentralized at-home administration, on-site administration at partner schools, tutoring centers and clinical practices, or a hybrid of the two. For all pediatric sessions a trained adult, who may be a parent, legal guardian, or a trained study team member such as a tutor or educator, is required to be present and supervising for the duration of each session. Supervisors complete training on electrode placement, device operation, and adverse event recognition before the first session.
The protocol declares a bounded parameter envelope within which specific stimulation parameters, reading instruction methods, partner sites, and assessment instruments may be selected per cohort without protocol amendment. All parameters operate within the LOTES-2023 limited-output standard for transcranial electrical stimulation devices. For pediatric participants the declared envelope permits 0 to 2 mA average absolute current, a maximum current density of 2 mA/cm2 at the electrode contact area, a maximum session duration of 60 minutes subject to a 6000 mC total-charge-per-session ceiling, and a maximum of 30 total sessions per participant. Anticipated session durations are 20 to 30 minutes.
Concurrent structured reading instruction may follow any evidence-based structured literacy method, including Orton-Gillingham-based and Lindamood-Bell approaches.
Reading assessments are administered by qualified practitioners, including reading specialists, certified educators, or other personnel trained in administration of the selected instrument.
Because assessment instruments and specific stimulation parameters are selected per cohort within the declared envelope, each enrollment cohort has a cohort-specific Statistical Analysis Plan finalized and locked prior to unblinding of that cohort.
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：Alec Sheffield, PhD
- 電話番号：617-657-3348
- メール：alec@generalneuro.com
研究連絡先のバックアップ
- 名前：Luke Knoble
- メール：luke@generalneuro.com
研究場所
-
-
Massachusetts
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Boston、Massachusetts、アメリカ、02131
- 募集
- General Neuro, Inc.
-
コンタクト：
- Alec Sheffield, PhD
- 電話番号：617-657-3348
- メール：info@generalneuro.com
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Children aged 7 to 17 years inclusive
- Diagnosed with developmental dyslexia or related reading disability, OR exhibiting reading difficulties consistent with developmental dyslexia (for example, performing below the participant's expected grade level on a standardized reading assessment), as identified by the participant's educator, reading practitioner, caregiver, or clinician. A formal clinical diagnosis is not required for enrollment.
- Concurrently receiving or able to receive structured reading instruction during the intervention period
- Parent or legal guardian able and willing to provide informed permission
- Participant able and willing to provide age-appropriate assent
Exclusion Criteria:
- History of epilepsy or any seizure disorder
- Active skin disease, open wounds, or significant skin irritation at electrode contact sites
- Implanted electronic medical devices where stimulation would be contraindicated per device manufacturer guidance or investigator judgment after individual risk assessment
- Significant cognitive impairment beyond reading-related difficulties that would interfere with assent or study participation
- Any other condition that, in the investigator's judgment, would compromise participant safety or the integrity of the study data
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Active Stimulation
Participants receive active transcranial electrical stimulation delivered through a non-invasive scalp-mounted headset while completing structured reading instruction.
Stimulation amplitude and session duration are selected per cohort from the declared pediatric parameter envelope, with current ramping at session start and end.
Sessions are typically 20 to 30 minutes, with a maximum of 30 total sessions per participant.
A trained adult supervises every session.
|
Non-invasive transcranial electrical stimulation delivered by a scalp-mounted headset within the LOTES-2023 limited-output envelope, paired with structured reading instruction.
Pediatric declared range 0 to 2 mA average absolute current, maximum current density 2 mA/cm2 at the electrode contact area, maximum session duration 60 minutes subject to a 6000 mC per-session total charge limit, and a maximum of 30 total sessions per participant.
Electrodes are placed in standard cephalic or extracephalic montages targeting cortical regions implicated in reading networks.
The device is investigational and is not approved or cleared by the U.S. FDA.
|
|
偽コンパレータ：Sham Stimulation
Participants receive sham stimulation through the same non-invasive scalp-mounted headset while completing the same structured reading instruction.
Sham provides the sensory experience of stimulation onset without sustained current delivery.
The specific validated sham approach is selected and documented per cohort.
A trained adult supervises every session.
|
Sham stimulation delivered by the same scalp-mounted headset, providing the initial cutaneous sensory experience of stimulation onset without sustained current delivery, paired with the same structured reading instruction.
The specific validated sham approach is selected per cohort and documented in the corresponding cohort plan.
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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 |
|---|---|---|
|
Change from baseline in TOWRE-2 Total Word Reading Efficiency index
時間枠：Baseline to end of intervention period, up to 10 weeks
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Change in the Total Word Reading Efficiency index of the Test of Word Reading Efficiency, Second Edition (TOWRE-2), a timed measure of word reading efficiency administered by a qualified practitioner.
Scores are reported as age-normed standard scores with a mean of 100 and a standard deviation of 15.
Higher scores indicate greater word reading efficiency.
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Baseline to end of intervention period, up to 10 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in CTOPP-2 Phonological Awareness Composite score
時間枠：Baseline to end of intervention period, up to 10 weeks
|
Change in the Phonological Awareness Composite score of the Comprehensive Test of Phonological Processing, Second Edition (CTOPP-2), administered by a qualified practitioner.
Scores are reported as age-normed standard scores with a mean of 100 and a standard deviation of 15.
Higher scores indicate stronger phonological awareness.
|
Baseline to end of intervention period, up to 10 weeks
|
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Change from baseline in CTOPP-2 Rapid Symbolic Naming Composite score
時間枠：Baseline to end of intervention period, up to 10 weeks
|
Change in the Rapid Symbolic Naming Composite score of the Comprehensive Test of Phonological Processing, Second Edition (CTOPP-2), administered by a qualified practitioner.
Scores are reported as age-normed standard scores with a mean of 100 and a standard deviation of 15.
Higher scores indicate faster symbolic naming.
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Baseline to end of intervention period, up to 10 weeks
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Change from baseline in WJ IV Reading Fluency cluster score
時間枠：Baseline to end of intervention period, up to 10 weeks
|
Change in the Reading Fluency cluster score of the Woodcock-Johnson IV Tests of Achievement (WJ IV ACH), administered by a qualified practitioner.
Scores are reported as age-normed standard scores with a mean of 100 and a standard deviation of 15.
Higher scores indicate greater reading fluency.
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Baseline to end of intervention period, up to 10 weeks
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Incidence of adverse events
時間枠：Through the intervention period and follow-up, up to 12 months
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Number and severity of adverse events reported, including tingling, itching or warmth under the electrodes, skin redness, headache, fatigue, difficulty sleeping, dizziness or lightheadedness, phosphenes, and skin irritation.
Adverse events are captured by app-mediated or device-prompted self-report after each session, investigator queries at scheduled assessments, and participant- or supervisor-initiated reports.
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Through the intervention period and follow-up, up to 12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in WJ IV Passage Comprehension score
時間枠：Baseline to end of intervention period, up to 10 weeks
|
Change in the Passage Comprehension score of the Woodcock-Johnson IV Tests of Achievement (WJ IV ACH), administered by a qualified practitioner.
Scores are reported as age-normed standard scores with a mean of 100 and a standard deviation of 15.
Higher scores indicate stronger reading comprehension.
Analyzed as an exploratory outcome.
|
Baseline to end of intervention period, up to 10 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Alec Sheffield, PhD、General Neuro Inc.
研究記録日
主要日程の研究
研究開始 (推定)
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
- GN-001-B
- GN-001 (その他の識別子：General Neuro, Inc.)
- 20262153 (その他の識別子：WCG)
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
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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