- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07916207
Acute Effects of Accelerated Transcranial Direct Current Stimulation on Leg Muscle Strength in Physically Inactive College Students (ACC-tDCS)
Effects of Accelerated Transcranial Direct Current Stimulation on Lower Limb Muscle Strength in Adults: a Randomized, Single-Blind, Sham-Controlled Trial in Physically Inactive College Students
The goal of this clinical trial is to learn whether accelerated transcranial direct current stimulation (tDCS), in which two sessions of stimulation are delivered within a single day, can immediately improve leg muscle strength in physically inactive college students. tDCS is a non-invasive technique that applies a weak, constant electrical current through electrodes on the scalp to change the excitability of the brain area under the electrode. In this study, stimulation targets the leg area of the primary motor cortex.
The main questions it aims to answer are:
- Does a single application of accelerated tDCS or single-session tDCS improve maximal strength, explosive strength and muscular endurance of the knee muscles more than sham stimulation?
- Does dividing stimulation into two 10-minute sessions separated by 3 or 20 minutes produce larger immediate effects than one 10-minute or one 20-minute session?
Researchers will compare five groups: two accelerated tDCS groups (two 10-minute sessions separated by 3 or 20 minutes), two single-session tDCS groups (one 10-minute or one 20-minute session) and a sham stimulation group.
Participants will:
- Attend one laboratory visit
- Complete isokinetic strength tests of the knee flexors and extensors of both legs before stimulation
- Receive the assigned stimulation protocol while sitting at rest
- Repeat the same strength tests immediately after stimulation and report any sensations or discomfort related to stimulation
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Background: Muscle strength comprises maximal strength, explosive strength and muscular endurance. Anodal tDCS over the primary motor cortex (M1) can increase motor cortical excitability, and several studies have reported improvements in muscle strength after single sessions. Neurophysiological studies show that a second session of anodal tDCS delivered within the after-effect period of the first (for example after 3 or 20 minutes) prolongs the increase in cortical excitability, whereas longer intervals do not. Protocols that deliver two or more sessions within one day are termed accelerated tDCS. Accelerated protocols have been applied in cognitive and clinical research, but their effects on muscle strength have not been examined.
Objective: To compare the acute effects of accelerated and single-session anodal tDCS over M1 on maximal strength, explosive strength and muscular endurance of the lower limbs in physically inactive college students.
Design: Single-center, randomized, single-blind, sham-controlled, five-arm parallel-group trial conducted at Beijing Sport University, Beijing, China. The protocol was approved by the Sports Science Experiment Ethics Committee of Beijing Sport University (No. 2025391H), and all participants provide written informed consent.
Participants: Seventy-five physically inactive college students aged 18 to 25 years (15 per group). Physical inactivity is defined as fewer than three sessions per week of moderate-intensity exercise lasting at least 30 minutes during the previous 3 months.
Randomization and blinding: Randomization is stratified by sex. A researcher not involved in testing or stimulation generates separate random number sequences for men and women in SPSS 27.0 and allocates participants of each sex to the five groups. Participants are blinded to the stimulation condition, and the researchers who collect and analyze the data are not involved in group allocation.
Interventions: tDCS is delivered with a dual-channel stimulator (TCS-E2, Shenzhen Yingchi Technology Co., Ltd., Shenzhen, China) through saline-soaked sponge electrodes (35 cm2, 5 x 7 cm). The anode is placed over Cz (leg area of M1), located according to the international 10-20 system and confirmed with a positioning cap, and the cathode over Fpz. Active stimulation is delivered at 1 mA. The five groups are: (1) two 10-minute sessions separated by 3 minutes; (2) two 10-minute sessions separated by 20 minutes; (3) one 10-minute session; (4) one 20-minute session; (5) sham stimulation, in which current is ramped up over 15 seconds and down over 15 seconds and the electrodes remain in place for 10 minutes (n = 8) or 20 minutes (n = 7). Participants remain seated at rest during stimulation.
Procedures: At a single laboratory visit, participants complete a 3-minute warm-up on the isokinetic dynamometer and the baseline test (T0). After a 10-minute rest, the assigned stimulation protocol is administered, and the same tests are repeated immediately after stimulation (T1), followed by a cool-down. Tests are performed on a Biodex System 4 Pro dynamometer in reciprocal concentric mode for the knee flexors and extensors of both legs, with the right leg tested first, in the order maximal strength, explosive strength and muscular endurance. Participants are asked to avoid strenuous exercise, sleep deprivation, alcohol, caffeine and related medications for 24 hours before testing. Sensations and adverse effects are recorded after the intervention with a transcranial electrical stimulation sensation questionnaire.
Outcomes: Peak torque at 60 degrees per second (maximal strength), average power at 180 degrees per second (explosive strength) and work fatigue during 20 repetitions at 180 degrees per second (muscular endurance) of the right and left knee flexors and extensors.
Sample size: An a priori calculation in G*Power 3.1 for a repeated-measures analysis of variance (effect size f = 0.35, alpha = 0.05, power = 0.80) indicated a minimum of 66 participants. Seventy-five participants (15 per group) are recruited to allow for dropout.
Statistical analysis: Change scores (T1 minus T0) are compared among the five groups with one-way analysis of variance, followed by least significant difference post hoc tests when the omnibus test is significant. Partial eta-squared and Cohen's d are reported as effect sizes. Welch's analysis of variance is used when variances are unequal, and a sensitivity analysis excluding extreme values (beyond three times the interquartile range) is performed. All randomized participants are included in the analysis, and the significance level is set at 0.05.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 100084
- Beijing Sport University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Aged 18 to 25 years
- College student
- Physically inactive, defined as fewer than three sessions per week of moderate-intensity exercise lasting at least 30 minutes during the previous 3 months
- Normal or corrected-to-normal vision, without color blindness, color weakness or dyslexia
- Able to refrain from strenuous exercise, sleep deprivation, and alcohol, caffeine and related medications for 24 hours before testing
- Willing to provide written informed consent
Exclusion Criteria:
- Personal or family history of epilepsy, stroke or other neurological or psychiatric disorders
- Implanted medical devices or metal implants remaining from surgery
- Pregnancy
- Any other contraindication to transcranial direct current stimulation
- Participation in any other brain stimulation study during the study period
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Accelerated tDCS, 3-minute interval
Two 10-minute sessions of anodal tDCS at 1 mA over the leg area of the primary motor cortex (anode over Cz, cathode over Fpz), separated by a 3-minute interval and delivered once at a single laboratory visit (n = 15). |
Anodal transcranial direct current stimulation delivered as two 10-minute sessions at 1 mA within one visit, with an inter-session interval of 3 or 20 minutes according to the assigned arm. Stimulation is delivered with a dual-channel stimulator (TCS-E2, Shenzhen Yingchi Technology Co., Ltd., China) through saline-soaked sponge electrodes (35 cm2), with the anode over Cz and the cathode over Fpz.
Altri nomi:
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Sperimentale: Accelerated tDCS, 20-minute interval
Two 10-minute sessions of anodal tDCS at 1 mA over the leg area of the primary motor cortex (anode over Cz, cathode over Fpz), separated by a 20-minute interval and delivered once at a single laboratory visit (n = 15). |
Anodal transcranial direct current stimulation delivered as two 10-minute sessions at 1 mA within one visit, with an inter-session interval of 3 or 20 minutes according to the assigned arm. Stimulation is delivered with a dual-channel stimulator (TCS-E2, Shenzhen Yingchi Technology Co., Ltd., China) through saline-soaked sponge electrodes (35 cm2), with the anode over Cz and the cathode over Fpz.
Altri nomi:
|
|
Comparatore attivo: Single-session tDCS, 10 minutes
One continuous 10-minute session of anodal tDCS at 1 mA over the leg area of the primary motor cortex (anode over Cz, cathode over Fpz), delivered once at a single laboratory visit (n = 15). |
Anodal transcranial direct current stimulation at 1 mA delivered as one continuous session lasting 10 or 20 minutes according to the assigned arm, using the same stimulator, electrodes and montage as the accelerated protocols.
Altri nomi:
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Comparatore attivo: Single-session tDCS, 20 minutes
One continuous 20-minute session of anodal tDCS at 1 mA over the leg area of the primary motor cortex (anode over Cz, cathode over Fpz), delivered once at a single laboratory visit (n = 15). |
Anodal transcranial direct current stimulation at 1 mA delivered as one continuous session lasting 10 or 20 minutes according to the assigned arm, using the same stimulator, electrodes and montage as the accelerated protocols.
Altri nomi:
|
|
Comparatore fittizio: Sham tDCS
Same electrode montage as the active groups. Current is ramped up over 15 seconds and down over 15 seconds (30 seconds in total), and the electrodes remain in place for 10 minutes (n = 8) or 20 minutes (n = 7) to match the duration of the single-session protocols (n = 15). |
Sham transcranial direct current stimulation using the same stimulator, electrodes and montage. The current is delivered for 30 seconds (15-second ramp-up and 15-second ramp-down) and then switched off while the electrodes remain in place.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Peak Torque of the Knee Flexors and Extensors at 60 Degrees per Second
Lasso di tempo: Baseline (before stimulation) and immediately after the end of stimulation, on the single study day (Day 1)
|
Maximal strength is assessed as peak torque (newton-meters) during five consecutive maximal concentric knee flexion-extension cycles at an angular velocity of 60 degrees per second on an isokinetic dynamometer (Biodex System 4 Pro). The right and left knee flexors and extensors are assessed separately, with the right leg tested first. Change is calculated as the post-stimulation value minus the baseline value. |
Baseline (before stimulation) and immediately after the end of stimulation, on the single study day (Day 1)
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Change in Average Power of the Knee Flexors and Extensors at 180 Degrees per Second
Lasso di tempo: Baseline (before stimulation) and immediately after the end of stimulation, on the single study day (Day 1)
|
Explosive strength is assessed as average power (watts) during five consecutive knee flexion-extension cycles performed with maximal speed and effort at an angular velocity of 180 degrees per second on an isokinetic dynamometer (Biodex System 4 Pro). The right and left knee flexors and extensors are assessed separately. Change is calculated as the post-stimulation value minus the baseline value. |
Baseline (before stimulation) and immediately after the end of stimulation, on the single study day (Day 1)
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Change in Work Fatigue of the Knee Flexors and Extensors at 180 Degrees per Second
Lasso di tempo: Baseline (before stimulation) and immediately after the end of stimulation, on the single study day (Day 1)
|
Muscular endurance is assessed as work fatigue (percentage) during 20 consecutive knee flexion-extension cycles performed with maximal speed and effort at 180 degrees per second. Work fatigue = (1 - work in the last third of the repetitions / work in the first third) x 100. Higher values indicate greater fatigue. The right and left knee flexors and extensors are assessed separately. Change is calculated as the post-stimulation value minus the baseline value. |
Baseline (before stimulation) and immediately after the end of stimulation, on the single study day (Day 1)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants With Stimulation-Related Adverse Effects
Lasso di tempo: Immediately after the end of stimulation, on the single study day (Day 1)
|
Sensations and adverse effects related to stimulation (for example tingling, itching, burning sensation, headache and fatigue) are recorded with a transcranial electrical stimulation sensation questionnaire after the intervention. The number of participants reporting each adverse effect is summarized by group. |
Immediately after the end of stimulation, on the single study day (Day 1)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Rihua Liu, Master's Degree, Beijing Sport University
- Direttore dello studio: Fengxue Qi, doctoral degree, Beijing Sport University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025391H
- 2026075 (Altro numero di sovvenzione/finanziamento: Fundamental Research Funds for the Central Universities (Beijing Sport University Graduate Innovative Research Project))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
De-identified individual participant data underlying the results reported in the publication, including demographic characteristics and isokinetic strength outcomes, will be shared.
Periodo di condivisione IPD
Beginning after publication of the main results.
Criteri di accesso alla condivisione IPD
Data will be available from the corresponding author (Fengxue Qi, fengxue.qi@hotmail.com) upon reasonable request for non-commercial research purposes, subject to approval of the request and a data use agreement.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
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