Neural Mechanisms and Augmented Efficacy of High-definition Transcranial Electrical Stimulation on Upper-extremity Function in Patients With Subacute Stroke

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ \- 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).

Locations
Other Locations
Taiwan
New Taipei City Tucheng Hospital
NOT_YET_RECRUITING
New Taipei City
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Medical University Hospital
RECRUITING
Taipei
Contact Information
Primary
Mon-Ting Lin
B96401093@ntu.edu.tw
+886-972-652-480
Backup
Yi-Jing Huang
yijinghuang@ntu.edu.tw
+886-911-164-386
Time Frame
Start Date: 2024-08-15
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 152
Treatments
Experimental: Excitatory stimulation on the affected hemisphere & UE rehabilitation
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.
Experimental: Inhibitory stimulation on the unaffected hemisphere & UE rehabilitation
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.
Experimental: Simultaneous bilateral stimulation & UE rehabilitation
Combined with upper extremity rehabilitation of affected side.
Sham_comparator: Sham stimulation& UE rehabilitation
The sham control group will receive sham HD-tCES combined with upper extremity rehabilitation of affected side.
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov