- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07909317
Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury
Enhancing Motor Learning With Transcranial Electrical Stimulation for Upper Extremity Functional Restoration in People With Cervical Spinal Cord Injury
The goal of this pilot study is to find out how four different types of transcranial electrical stimulation (tES) affect brain activity, the process of acquiring new skills (also called motor learning), and hand function after cervical spinal cord injury (cSCI).
Participants will complete 5 study sessions: one sign-up session and four testing & intervention sessions. Total participation will take about 18 hours. During the sign-up session, researchers will: discuss study details, review the participant's health history to make sure that it is safe for them to participate, perform tests to ensure that the participant meets the study criteria, and collect the participant's demographic information. During each testing & intervention session, the participant will receive a different type of tES. Before and after getting tES, they will take part in tests that measure their brain activity and the strength, sensation, and function of their right hand.
Przegląd badań
Status
Warunki
Szczegółowy opis
Improved use of the upper extremities (UEs) is a paramount concern for most individuals with cervical spinal cord injury (cSCI). The majority of people with SCI have some remaining pathways connecting the cortical and spinal circuitry. Strengthening descending corticospinal circuits, which drive volitional control, has potential to have a significant impact on UE function. Therapeutic modalities that enhance descending drive via direct excitation of the cortical circuitry may be valuable adjuncts to neurorehabilitation training for people with SCI.
Transcranial electrical stimulation (tES) modulates cortical excitability via low intensity electrical stimulation applied to the scalp. It is an attractive candidate for use as an adjunct to standard neurorehabilitation training given its clinical accessibility; tES devices are cost effective, highly portable, require minimal training, and have short set-up times. Further, tES has been shown to improve implicit motor learning, a cornerstone of neurorehabilitation training. While the use of tES as a neuromodulatory intervention has been studied extensively in people with stroke, these modalities have received little attention in the realm of SCI neurorehabilitation research.
Multiple types of tES exist, including transcranial direct current stimulation (tDCS), transcranial pulsed current stimulation (tPCS), and transcranial random noise stimulation (tRNS). These modalities vary based on the applied waveform. Continuous, patterned, and variable waveforms are applied during tDCS, tPCS and tRNS, respectively. In addition to modulating cortical excitability, tDCS has been shown to improve implicit learning processes which are impaired after SCI. Preliminary evidence in neurologically intact individuals suggests that tPCS and tRNS may be more efficacious modulators of cortical excitability than tDCS. However, it is unknown whether these effects on cortical excitability carry over to improvements in implicit motor learning. Further, the type of tES that has the largest effect on motor learning and UE function in people with cSCI has yet to be determined. For this pilot project, the investigators will employ a sham-controlled, randomized crossover study designed to evaluate the comparative efficacy of four different types of tES (tDCS, tPCS, tRNS, and sham) in 12 participants with chronic cSCI via the following Specific Aims:
Aim 1. Quantify the effects of tDCS, tPCS, tRNS, and sham tES on implicit motor learning.
Aim 2. Quantify the effects of tDCS, tPCS, tRNS, and sham tES on UE function, strength and sensation.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30309
- Shepherd Center
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Kontakt:
- Jennifer Iddings, PhD
- Numer telefonu: 404-367-1239
- E-mail: jennifer.iddings@shepherd.org
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Główny śledczy:
- Jennfer A Iddings, PhD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- cervical spinal cord injury (neurological level C1-C8) that occurred at least one year ago
- International Standards for Neurological Classification of SCI/ASIA Impairment Scale (ISNCSCI/AIS) severity classification C or D
- self-reported limitations in right hand function
- volitional muscle activity in the right hand, as determined by a score ≥ 2 in at least one intrinsic hand muscle group evaluated in the Graded Redefined Assessment of Strength Sensibility and Prehension version 2 (GRASSP v2) strength subtest
- ability to follow instructions
- ability to communicate pain or discomfort
- ability and willingness to consent to participate in the study and authorize use of protected health information
Exclusion Criteria:
- spinal cord issues that are getting worse, such as degenerative or progressive vascular disorders of the spinal and/or spinal cord
- metal implant in the head
- history of uncontrolled seizures
- history of frequent or severe headaches
- damage to the nerves of the right arm/hand (lower motor neuron damage) as documented in the medical record, per participant report, or during in-person screening
- prior tendon or nerve transfer surgery in the right arm/hand
- severe pain, hypersensitivity, or contractures of the right arm/hand that would limit participation in arm and hand training
- broken skin or wounds on your head/scalp where stimulation will be applied
- if you're a woman, and you are pregnant, think you might be, or are actively trying to become pregnant
- you have any other health issue that the lead investigators think could make it unsafe for you to join the study
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: transcranial electrical stimulation (tES) + functional task practice (FTP)
Participants will participate in a single session of each of the three tES types being evaluated combined with upper extremity FTP. |
tDCS (waveform: monophasic and continuous) will be delivered for a duration of 20 minutes and intensity of 2 mA using two saline-soaked reusable sponge electrodes (35 cm2 each). The active electrode will be placed over the hand representation of the motor cortex controlling the right upper extremity (C3, 10-20 EEG system) and the reference electrode will be placed over the contralateral supraorbital area (FP2, 10-20 EEG system). The FTP component of intervention will occur concurrently with tDCS application and will consist primarily of task-oriented arm and hand activities. tPCS (waveform: monophasic square waves with 500 ms pulse duration and 50 ms inter-pulse interval) will be delivered for a duration of 20 minutes and intensity of 2 mA using two saline-soaked reusable sponge electrodes (35 cm2 each). The active electrode will be placed over the hand representation of the motor cortex controlling the right upper extremity (C3, 10-20 EEG system) and the reference electrode will be placed over the contralateral supraorbital area (FP2, 10-20 EEG system). The FTP component of intervention will occur concurrently with tPCS application and will consist primarily of task-oriented arm and hand activities. tRNS (waveform: 0-500 Hz random frequency and Gaussian white noise random intensity) will be delivered for a duration of 20 minutes and intensity range of +/-1 mA using two saline-soaked reusable sponge electrodes (35 cm2 each). The active electrode will be placed over the hand representation of the motor cortex controlling the right upper extremity (C3, 10-20 EEG system) and the reference electrode will be placed over the contralateral supraorbital area (FP2, 10-20 EEG system). The FTP component of intervention will occur concurrently with tRNS application and will consist primarily of task-oriented arm and hand activities. |
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Aktywny komparator: sham transcranial electrical stimulation (tES) + functional task practice (FTP)
Participants will participate in a single session of sham tES combined with upper extremity FTP. |
Sham tES will be delivered for a duration of 20 minutes and intensity of 0 mA using two saline-soaked reusable sponge electrodes (35 cm2 each). The active electrode will be placed over the hand representation of the motor cortex controlling the right upper extremity (C3, 10-20 EEG system) and the reference electrode will be placed over the contralateral supraorbital area (FP2, 10-20 EEG system). The FTP component of intervention will occur concurrently with sham tESapplication and will consist primarily of task-oriented arm and hand activities. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in brain activity
Ramy czasowe: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.
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Electroencephalography (EEG) event-related potential (ERP) amplitude will be recorded in the left parietofrontal network during performance of a modified serial reaction time task (mSRTT). |
Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.
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Change in brain connectivity
Ramy czasowe: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.
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Electroencephalography (EEG) alpha band parietofrontal connectivity will be recorded under two conditions: 1) resting state and 2) during performance of a modified serial reaction time task (mSRTT). |
Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in upper extremity (UE) function
Ramy czasowe: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.
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Function will be measured in the right UE using the Graded Redefined Assessment of Strength Sensibility and Prehension version 2 (GRASSP v2) quantitative prehension subtest. Participants will complete four tasks: pouring water from a bottle to a cup, moving nine pegs from one side of a board to the other, inserting a key into a lock and rotating, and fastening four nuts onto screws. Each task will be scored on a 0-5 scale (0: task cannot be conducted at all - 5: task conducted without difficulty using the expected grasp pattern) and timed (maximum of 75 seconds will be allowed per task). The number of drops during each task will also be recorded. The total score, time and number of drops for all four tasks will then be calculated. The maximum score is 20 with higher scores denoting better UE function. |
Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.
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Change in upper extremity (UE) strength
Ramy czasowe: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.
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Strength will be measured in the right UE using key pinch force. The participant will be positioned with the shoulder in neutral, elbow flexed at approximately 90º, and forearm and wrist in neutral. Force will be quantified with an electronic pinchmeter positioned between the middle phalanx of the index finger and thumb pad. The participant will be given a command of "ready, set, go" upon which they will be instructed to pinch as hard as possible for 3 seconds. Three trials will be completed with a 60 second rest period between trials, and the mean force will be calculated. |
Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.
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Change in upper extremity (UE) sensation
Ramy czasowe: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.
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Sensation will be measured in the right UE using the Graded Redefined Assessment of Strength Sensibility and Prehension version 2 (GRASSP v2) sensation subtest. Semmes-Weinstein monofilaments ranging in size from 3.61 to 6.65 will be used in three locations on the palmar surface of the hand while the participant's vision is occluded with a blindfold. The smallest monofilament (3.61) will be tested 3 times per location with 2/3 accurate responses indicating intact sensation. If the participant cannot detect the 3.61 filament at all locations, testing will continue with the next heaviest filament until the participant detects a filament at all three test locations or until testing with the heaviest filament is complete. In contrast to the 3.61 filament, the three other filaments will be tested once per location. The total score will be calculated by summing the scores for each test location. The maximum score is 12 with higher scores denoting better UE sensation. |
Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.
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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby ośrodkowego układu nerwowego
- Choroby Układu Nerwowego
- Rany i urazy
- Uraz, układ nerwowy
- Choroby rdzenia kręgowego
- Uszkodzenia rdzenia kręgowego
- Lecznictwo
- Kwasy nukleinowe
- Kwasy nukleinowe, nukleotydy i nukleozydy
- Dyscypliny i działania behawioralne
- Terapia stymulacji elektrycznej
- Terapia konwulsyjna
- Psychiatryczne terapie somatyczne
- Electroshock
- Techniki psychologiczne
- RNA
- RNA, Transfer, Aminokwasowo-Specyficzny
- RNA, Transfer
- Przezczaszkowa stymulacja prądu stałego
- RNA, Transfer, Ser
- TES
Inne numery identyfikacyjne badania
- 1123
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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