Stroke
Conditions
Interventions
tDCS+shamFES group:tDCS therapy combined with sham FES: tDCS (anode stimulation of affected side M1 area, cathode stimulation of contralateral supraorbital region, 1~2mA, 20min/session, once daily, 5
sham FES (electrodes placed on affected side triceps brachii, current intensity set and turned on for only 30 seconds then off, patients receive conventional rehabilitation training as well).
sham tDCS+FES group:Sham tDCS therapy combined with FES: sham tDCS (anode stimulation of affected side M1 area, cathode stimulation of contralateral supraorbital region, 1~2mA, 20min/session, once dai
FES (electrodes placed on affected side triceps brachii, current intensity set to induce muscle contraction, patients view elbow extension video and try to complete the movement as much as possible).
tDCS+FES group:tDCS therapy combined with FES: tDCS (anode stimulation of affected side M1 area, cathode stimulation of contralateral supraorbital region, 1~2mA, 20min/session, once daily, 5 times wee
sham tDCS+shamFES group:Sham tDCS therapy combined with sham FES: sham tDCS (anode stimulation of affected side M1 area, cathode stimulation of contralateral supraorbital region, 1~2mA, 20min/session,
Sponsors
Beijing Bo'ai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for stroke, confirmed by CT or MRI; 2. Aged 18-80 years old, regardless of gender; 3. First onset, unilateral limb paralysis; Brunnstrom stage of upper limb: ?-?; 4. Onset time between 2 weeks and 3 months; 5. Elbow muscle tone of the affected side 20/30 points (illiterate) or >24/30 points (literate)]; 7. No skull repair, no implants such as cardiac pacemakers or neurostimulators; 8. No pain sensation in the treatment area or patch allergy; 9. Voluntary participation and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with previous neuromuscular diseases, malignant tumors or other severe uncontrollable diseases, including heart, kidney or liver diseases, etc.; 2. Previous brain trauma or skull defect; 3. Sitting balance < grade 2, unable to maintain sitting position for more than 60 minutes; 4. Patients with moderate to severe depressive symptoms; 5. Those who are participating in other research trials that may affect the results of this study; 6. Those with contraindications to the intervention or fNIRS device (such as skull defects or abnormalities, etc.); 7. History of epilepsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Assessment of the Upper Extremity (FMA-UE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Ashworth Scale (MAS);Range of Motion (ROM);Limb Girth Measurement (LGM);Hand Function Classification (Hand Functionality Assessment);Simple Test of Upper Extremity Function (STEF);Gait Assessment;Berg Balance Scale (BBS);Montreal Cognitive Assessment (MoCA);Digit Span Test (DST);Stroop Color–Word Interference Test (SCWIT);Paced Auditory Serial Addition Test (PASAT);Symbol Digit Modalities Test (SDMT);Trail Making Test Part B (TMT-B);Improve the Barthel Index assessment;Quality of Life Evaluation Scale;Neurophysiological Parameters; | — |
Countries
China
Contacts
Public ContactHuang Fubiao
Beijing Bo'ai Hospital
Outcome results
None listed