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Dual-tDCS and Anodal PMC tDCS Over the Contralesional Hemisphere on the Upper Limb Function in Stroke Patients

18 dicembre 2021 aggiornato da: Turki Abualait

The Comparative Effects of Dual-tDCS and Anodal Premotor tDCS Over the Contralesional Hemisphere on the Upper Limb Function and Manual Dexterity in Patients With Chronic Stroke: Single-blinded Randomized Controlled Trial

Background: Transcranial direct current stimulation (tDCS) has been gaining increasing interest as a potential therapeutic tool to improve upper extremity (UE) rehabilitation outcomes following stroke. Within the concept of interhemispheric inhibition (IHI), most tDCS studies have applied anodal ipsilesional and/or cathodal contralesional primary motor cortex (M1) tDCS to rebalance IHI and enhance motor recovery. However, compelling evidence suggests that an excitation/inhibition model is oversimplified, and the role of both hemispheres in the encoding of information during motor learning should be acknowledged. Moreover, multiple lines of evidence have demonstrated the potential relevance of contralesional premotor cortex (PMC) for recovery after M1 injury.

Objective: We are aiming to investigate and compare the effects of two tDCS montages at different cortical sites (Dual-M1 vs. a-tDCS over contralesional PMC) by measuring the clinical outcomes of the most affected UE in patients with chronic subcortical stroke.

Methods: 35 participants will be randomly assigned to 1 of 3 groups (Group A received dual- M1 tDCS, Group B received a-tDCS over contralesional PMC, and Group C received sham stimulation). tDCS will be applied using intensity of 2 mA for 20 min. (5 times/week) for 2 consecutive weeks. Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT) will be used to quantify the UE functional motor ability. Box and Block Test (BBT) will be used for gross manual dexterity and Nine Hole Peg Test (NHPT) will be used to measure fine hand dexterity. All measurements will be taken pre-treatment (T0) and post-treatment (T1) immediately after the 10th session, then 4 weeks after the end of stimulation period (T2) to assess the long-term effects.

Expected results: This study would verify whether enhancing the motor cortical hyperexcitability in the contralesional hemisphere has a beneficial on recovery of the paretic hand, or regaining the balance of transcallosal inhibitory circuits between the motor areas in both hemispheres has more positive effects on the motor outcomes . This study would also provide a predictive approach to enable realistic rehabilitation goal-setting by identifying the proper tDCS montage for patients with stroke depending on their impairment level.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This experimental study will be conducted in a sham-controlled, single-blinded randomized controlled design. The subjects will be recruited - by convenience sampling - from the outpatient population of different governmental hospitals in Eastern Province of Saudi Arabia. Neurologists, Physiatrists and Physical therapists will be contacted to recruit potential subjects and IRB-approved letter will be sent to them. The subjects will be screened to determine whether a potential participant is eligible to be enrolled in the study or not. Only the principal investigator (PI) will conduct the screening procedures, which include reviewing medical record, in-person interview and administration of Mini-Mental State Examination. All screening activities will take 15-20 min., and they will be performed in a private screening room. Enrollment will occur after verifying the eligibility and obtaining the signed written consent form. Participants will be enrolled in the study only if they met all the inclusion criteria, which are:

  1. Male or Female participants aged ≥ 18
  2. First ever, unilateral, ischemic, subcortical stroke in the territories supplied by the Middle Cerebral Artery (MCA) verified by brain imaging, at chronic stage (≥ 6 months).
  3. Upper Extremity impairment verified by Fugl-Meyer Assessment-Upper Extremity (FMA-UE).
  4. Mini Mental State Examination Score ≥ 24.

All the participants were receiving conventional physical therapy and occupational therapy sessions (1-2 times/week).

The Exclusion Criteria included the following:

  1. History of epileptic seizures.
  2. Pre-stroke motor impairment(s) affecting UE.
  3. Presence of UE contractures or deformities.
  4. Botulinum toxin to UE muscles in the last 6 months.
  5. Presence of damaged skin on the scalp that would interfere with tDCS stimulation.
  6. Individuals with metallic implant in the brain or medical devices (i.e., cardiac pacemaker, deep brain stimulator, cochlear implants).
  7. Use of CNS-affecting drugs.
  8. Additional neurological or psychiatric problem.
  9. Pregnancy.

After enrollment, all participants will be scheduled to receive 10 sessions over two consecutive weeks (5 sessions/week). Each participant will be seen initially (1st visit) for about 90 min. to conduct all baseline measurements (T0), which will include clinical examinations using different standardized tests for upper limb function, and to conduct the experiment. The follow up sessions (8 sessions) will last for around 30 min. (10 min. for preparation and employing the electrodes + 20 min. for the stimulation). The 10th session will last for about 90 min. to carry out the measurement tests (T1) and to conduct the last stimulation session. The final visit will be scheduled to be 4 weeks after the 10th session to evaluate the long-term effects using the same measurement tests (T2).

All the participants will be blinded to the type of stimulation they received. The PI will take all the baseline measurements (T0), post-stimulation measurements immediately after the 10th session (T1), and long-term effects 4 weeks after the end of the stimulation period (T2). The PI will carry out all tDCS sessions as well.

All the participants will be randomly assigned, using opaque envelopes, to one of three groups:

  • Group A (n=11) receive dual-tDCS
  • Group B (n=13) receive a-tDCS over PMC in the contralesional hemisphere, and
  • Group C (n=11) receive sham stimulation.

This study protocol has been approved by the IRB from the research ethics committee in Imam Abdulrahman Bin Faisal University.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

35

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Arabia Saudita
    • Eastern
      • Dammam, Eastern, Arabia Saudita, 32210
        • BrainStim Lab, Imam Abdulrahman Bin Faisal University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. First ever, unilateral, ischemic, subcortical stroke in the territories supplied by the Middle Cerebral Artery (MCA) verified by brain imaging, at chronic stage (≥ 6 months).
  2. Upper Extremity impairment verified by Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
  3. Mini Mental State Examination Score ≥ 24

Exclusion Criteria:

  1. History of epileptic seizures.
  2. Pre-stroke motor impairment(s) affecting UE.
  3. Presence of UE contractures or deformities.
  4. Botulinum toxin to UE muscles in the last 6 months.
  5. Presence of damaged skin on the scalp that would interfere with tDCS stimulation.
  6. Individuals with metallic implant in the brain or medical devices (i.e., cardiac pacemaker, deep brain stimulator, cochlear implants).
  7. Use of CNS-affecting drugs.
  8. Additional neurological or psychiatric problem.
  9. Pregnancy.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Dual-M1 tDCS
In the M1- dual tDCS montage, the anodal electrode will be placed above ipsilesional M1 and the cathode will be positioned over contralesional M1.
Dispositivo: Dual M1-tDCS
In the M1- dual tDCS montage, the anodal electrode will be placed above ipsilesional M1 and the cathode will be positioned over contralesional M1.
Sperimentale: a-tDCS over contralesional PMC
In the anodal-tDCS for PMC, the anodal electrode will be placed over the contralesional PMC. The PMC is defined as being 2.5 cm anterior to the M1. The cathodal electrode will be positioned over the contralateral suborbital region
Dispositivo: a-tDCS over contralesional PMC
In the anodal-tDCS for PMC, the anodal electrode will be placed over the contralesional PMC. The PMC is defined as being 2.5 cm anterior to the M1. The cathodal electrode will be positioned over the contralateral suborbital region
Comparatore fittizio: Sham tDCS
For sham stimulation, there is no particular electrode configuration to be followed, thus, 6 participants will receive sham stimulation with the configuration will be used in group A, and 5 participants will receive sham stimulation with the configuration will be used in group B. By pressing the sham button, the current will automatically ramped up over 10 sec. till reaching 1 mA, then it will be decreased gradually over 30 seconds till turning off the apparatus. This is to ensure the typical initial itching sensation
Dispositivo: Sham tDCS
For sham stimulation, there is no particular electrode configuration to be followed, thus, 6 participants will receive sham stimulation with the configuration will be used in group A, and 5 participants will receive sham stimulation with the configuration will be used in group B. By pressing the sham button, the current will automatically ramped up over 10 sec. till reaching 1 mA, then it will be decreased gradually over 30 seconds till turning off the apparatus. This is to ensure the typical initial itching sensation

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline 'Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)' at 4 weeks
Lasso di tempo: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
the most frequently used outcome measure when assessing UE function after stroke within the research context (Santisteban et al., 2016). We will exclude the 3 reflex items because they make no difference to the overall scores of the test (Gladstone, Danells and Black, 2002; Woodbury et al., 2007; Woytowicz et al., 2017). It is composed of 30 items, each scored on a scale of 0 to 2. It has an excellent overall reliability (Duncan, Propst and Nelson, 1983; Sanford et al., 1993), validity and responsiveness as an indicator of motor impairment severity across different stroke recovery time points (Platz et al., 2005; Hsieh et al., 2009).
T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline 'Action Research Arm Test (ARAT)' at 4 weeks
Lasso di tempo: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
is a standardized, observational measure of UE functional capability for adult stroke survivors. It includes 19 items categorized into four subscales (grasp, grip, pinch and gross movement). Task performance on each item is rated on a 4-point ordinal scale, ranging from 0 (no movement) to 3 (movement performed normally) (Yozbatiran, Der-Yeghiaian and Cramer, 2008).
T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
Change from Baseline 'Box and Block Test (BBT)' at 4 weeks
Lasso di tempo: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
to assess gross manual dexterity. It consists of a wooden box divided by a partition into two equal compartments with 150 wooden blocks placed in one compartment. The participants will be given 60 seconds to move, one by one, as many 2.5 cm blocks as possible from one compartment to the other using only the most affected hand. 15-second trial will be allowed for each participant at the beginning to ensure adequate understanding of the task. BBT has excellent test-retest reliability when tested on more affected (r = 0.98) and less affected hand (r = 0.93) (Chen et al., 2009).
T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
Change from Baseline 'Nine Hole Peg Test (NHPT)' at 4 weeks
Lasso di tempo: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
is a finger dexterity measure involving timed performance to insert and remove 9 pegs from holes in a wooden board. It showed excellent test retest reliability (Chen et al., 2009), adequate to excellent intra-rater reliability and excellent inter-rater reliability (Heller et al., 1987).
T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Turki Abualait

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 novembre 2017

Completamento primario (Effettivo)

10 marzo 2020

Completamento dello studio (Effettivo)

14 marzo 2020

Date di iscrizione allo studio

Primo inviato

16 novembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

18 dicembre 2021

Primo Inserito (Effettivo)

6 gennaio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 gennaio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 dicembre 2021

Ultimo verificato

1 dicembre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IAU (Istanbul Arel University)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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