High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation
A legfontosabb adatok
- Ki végzi
- National Taiwan University Hospital
- Hol
- Hsinchu, New Taipei City és Taipei (Tajvan)Mind a 3 helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 152 fő, tervezett
- Kezdés
- 2024. aug. 15.
- Várható befejezés
- 2027. nov. 30.
- A vizsgálat típusa
- Beavatkozással járó, 4 csoportAz egyik csoport színlelt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- HD-tES
- Sham HD-tES
- UE rehabilitation
- HD-tES (Bilateral)
- A regiszteradat frissítve
- 2026. augusztus 20.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat egészséges felnőtteket és stroke után egyik oldali gyengeséggel élő felnőtteket keres. Az agystimulációt vizsgálják a kar felépülésének segítésére.
- Életkor
- 18 éves vagy idősebb
- Nem
- Férfiak és nők is részt vehetnek.
- A betegség stádiuma
- Egészséges, jobbkezes önkéntesek vagy stroke-betegek. Az egyik rész a stroke után több mint 6 hónappal jelentkezőket várja. A másik rész a stroke után 7 naptól 6 hónapig terjedő időszakban lévőket, Brunnstrom III–V. szintű karfelépüléssel és súlyos izomfeszesség nélkül (Modified Ashworth Scale ≤ 2).
- Korábbi kezelés
- Nem vehet részt, aki más agystimulációs kezelésben részesül.
A részvétel fő kizáró okai
- Epilepszia, pitvarfibrilláció, fémimplantátum, szívritmus-szabályozó, koponyahiány vagy megnövekedett koponyaűri nyomás a kórelőzményben
- Sérült bőr, seb vagy fekély a fejen vagy az elektródák helyén
- Más súlyos agyi vagy mentális betegség, vagy az agyműködést illetve a rohamküszöböt befolyásoló gyógyszerek tartós szedése
- Várandós vagy szoptató nők
- Súlyos gondolkodási zavar, afázia, féloldali elhanyagolás, illetve a kar ízületi és izomproblémái (szubakut stroke rész)
A regiszter feltételei, szó szerint
Mind a 47 feltétel megnézéseKevesebb
Ki vehet részt
- Sub-Project 1 (Healthy)
- Adults aged 18 and above
- Confirmed right-handedness using the Edinburgh Handedness Inventory; Sub-Project 1 (Post-stroke patients)
- Aged 18 and above
- Diagnosed with stroke
- Post-stroke for more than 6 months
- Unilateral hemiparesis; Sub-Project 2 (Subacute-stroke patients)
- Aged 18 and above
- Diagnosed with stroke
- Stroke occurred between 7 days to 6 months ago
- Unilateral hemiparesis
- Degree of recovery for proximal and distal movements of the affected upper limb is Brunnstrom stage III to V
- No severe muscle spasticity in any segments of the affected upper limb (Modified Ashworth Scale ≤ 2)
Ki nem vehet részt
- Pregnancy or lactating women. (If female, must be postmenopausal or surgically sterilized. Fertile women must have a negative pregnancy test result. Fertile female patients engaging in heterosexual intercourse, as well as fertile male patients with fertile female partners, must agree to use effective contraception during the trial period and for 4 months after the last dose of the investigational drug, such as oral contraceptives, dual barrier methods, intrauterine devices, or abstain from sexual intercourse during this period; non-fertile women are those who have undergone bilateral oophorectomy or are postmenopausal.)
- Undergoing other invasive or non-invasive brain stimulation therapies
- Pregnancy or lactating women. (If female, must be postmenopausal or surgically sterilized. Fertile women must have a negative pregnancy test result. Fertile female patients engaging in heterosexual intercourse, as well as fertile male patients with fertile female partners, must agree to use effective contraception during the trial period and for 4 months after the last dose of the investigational drug, such as oral contraceptives, dual barrier methods, intrauterine devices, or abstain from sexual intercourse during this period; non-fertile women are those who have undergone bilateral oophorectomy or are postmenopausal.)
- Undergoing other invasive or non-invasive brain stimulation therapies
- Pregnancy or lactating women. (If female, must be postmenopausal or surgically sterilized. Fertile women must have a negative pregnancy test result. Fertile female patients engaging in heterosexual intercourse, as well as fertile male patients with fertile female partners, must agree to use effective contraception during the trial period and for 4 months after the last dose of the investigational drug, such as oral contraceptives, dual barrier methods, intrauterine devices, or abstain from sexual intercourse during this period; non-fertile women are those who have undergone bilateral oophorectomy or are postmenopausal.)
- History of neurological disorders (e.g., stroke, brain tumor, epilepsy), psychiatric disorders (e.g., substance abuse, major depression, schizophrenia, bipolar disorder), or musculoskeletal disorders of the upper limb
- Contraindications to transcranial electrical stimulation, including history of epilepsy, atrial fibrillation, presence of metal implants, cardiac pacemakers, convexity skull defects, or increased intracranial pressure
- Skin allergies, contact dermatitis, abnormal pain, hypersensitivity to pain, wounds, or ulcers on the head
- History of alcohol or substance abuse
- Long-term use of central nervous system affecting medications (such as antidepressants, sedatives) or other medications that may affect seizure threshold
- Other conditions deemed unsuitable for transcranial electrical or magnetic stimulation by a physician
- Affiliation with any research institution/execution unit (e.g., students from NTU, Taipei Medical University); Sub-Project 1 (Post-stroke patients)
- Contraindications to transcranial electrical stimulation include a history of epilepsy, atrial fibrillation, presence of metal implants, cardiac pacemakers, convexity skull defects, or increased intracranial pressure
- Skin allergies, contact dermatitis, abnormal pain, hypersensitivity to pain, wounds, or ulcers on the head
- Severe neurological or psychiatric disorders other than stroke (such as major depression, schizophrenia, substance abuse, organic brain diseases, Parkinson's disease, brain tumors)
- Use of medications that may lower the seizure threshold
- History of alcohol or substance abuse
- Long-term use of central nervous system affecting medications (such as antidepressants, sedatives) or other medications that may affect seizure threshold
- Other conditions deemed unsuitable for transcranial electrical or magnetic stimulation by a physician; Sub-Project 2 (Subacute-stroke patients)
- Contraindications to transcranial electrical stimulation include a history of epilepsy, atrial fibrillation, presence of metal implants, cardiac pacemakers, convexity skull defects, or increased intracranial pressure
- Skin allergies, contact dermatitis, abnormal pain, hypersensitivity to pain, wounds, or ulcers on the head
- Severe neurological or psychiatric disorders other than stroke (such as major depression, schizophrenia, substance abuse, organic brain diseases, Parkinson's disease, brain tumors)
- Use of medications that may lower the seizure threshold
- Severe cognitive impairment or receptive or global aphasia making it difficult to understand instructions
- History of alcohol or substance abuse
- Long-term use of central nervous system affecting medications (such as antidepressants, sedatives) or other medications that may affect seizure threshold
- Other conditions deemed unsuitable for transcranial electrical or magnetic stimulation by a physician
- Sub-Project 1 (Healthy)
- Participation in other invasive or non-invasive brain stimulation research studies
- Damaged skin at the stimulation site, electrode contact, or device wearing site
- Damaged skin at the stimulation site, electrode contact, or device wearing site
- Other muscle and joint problems affecting upper limb function, such as joint contractures, rheumatoid arthritis, myositis ossificans
- Hemineglect (including visual, auditory, or sensory neglect)
- Damaged skin at the stimulation site, electrode contact, or device wearing site
Helyszínek itt: Tajvan
- National Taiwan University Hospital Hsin Chu BranchHsinchu, TajvanContact: Ying Chun Chen, M.D.Toborzás még nem indult
- New Taipei City TuCheng HospitalNew Taipei City, TajvanContact: Pei-Chien HsiehToborzás még nem indult
- National Taiwan University HospitalTaipei, TajvanContact: Yi-Jing Huang, PhDRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
Upper limb hemiparesis is the most common sequelae in patients, severely impacting their independence and quality of life. Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. It can induces long-term potentiation-like or long-term depression-like effects, thereby modulating the cortical excitability. In recent years, researchers have developed high-definition (HD) devices, which integrate high definition ring electrode configurations and incorporate direct current with theta burst stimulation waveforms. Diverging from traditional transcranial direct current stimulation (tDCS), which applies weak currents (0.5-2 mA) through two large sponge electrodes (25~35 cm\^2) externally to the scalp for widespread non-specific cortical stimulation, HD-tES employs an array of small-area electrodes (1 cm\^2) to control current distribution over localized cortical regions, thereby enhancing spatial accuracy. However, there is a lack of studies validating the optimal waveform for HD-tES, as well as clinical evidence in subacute stroke populations. The optimal unilateral versus bilateral stimulation modes and their neurological mechanisms for stroke rehabilitation also remain uncertain.
A vizsgálat 4 csoportja
- Excitatory stimulation on the affected hemisphere & UE rehabilitationA vizsgált kezelés
10 minutes sham inhibitory HD-tES over the unaffected hemisphere's M1 followed by 10 minutes of excitatory HD-tES over the affected hemisphere's M1, combined with upper extremity rehabilitation of affected side.
Kezelés: HD-tES és UE rehabilitation
- Inhibitory stimulation on the unaffected hemisphere & UE rehabilitationA vizsgált kezelés
10-minute active inhibitory HD-tES over the unaffected hemisphere's M1 followed by 10 minutes of sham excitatory HD-tES over the affected hemisphere's M1, combined with upper extremity rehabilitation of affected side.
Kezelés: HD-tES és UE rehabilitation
- Simultaneous bilateral stimulation & UE rehabilitationA vizsgált kezelés
Combined with upper extremity rehabilitation of affected side.
Kezelés: HD-tES és HD-tES (Bilateral)
- Sham stimulation& UE rehabilitationSzínlelt kezelés, összehasonlításként
The sham control group will receive sham HD-tCES combined with upper extremity rehabilitation of affected side.
Kezelés: Sham HD-tES és UE rehabilitation
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Neural Mechanisms and Augmented Efficacy of High-definition Transcranial Electrical Stimulation on Upper-extremity Function in Patients With Subacute Stroke
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
- A regiszteradat frissítve
- 2026. augusztus 20.