Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409143
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-07
Brief Title:
High-definition Transcranial Electrical Stimulation for Upper Extremity Rehabilitation
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Neural Mechanisms and Augmented Efficacy of High-definition Transcranial Electrical Stimulation on Upper-extremity Function in Patients With Subacute Stroke
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 05-2 mA through two large sponge electrodes 2535 cm2 externally to the scalp for widespread non-specific cortical stimulation HD-tES employs an array of small-area electrodes 1 cm2 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
Detailed Description:
This project comprises two sub-projects
1 Investigation of Neuromodulatory Effects of Stimulation Waveforms and Optimal Stimulation Waveform for Patients with Stroke a crossover trial will compare the effects of seven high-definition transcranial electrical stimulation HD-tES waveforms on neural excitatory or inhibitory activity in healthy adults These waveforms include three excitatory wave forms anodal direct current aDC intermittent theta burst stimulation iTBS and a combination of aDC and iTBS aDCiTBS and three inhibitory wave forms cathodal direct current cDC continuous theta burst stimulation cTBS and a combination of cDC and cTBS cDCcTBS along with a sham stimulation condition Changes in cortical excitability over a 2-hour period before and after stimulation will be tracked
Validation of the optimal stimulation waveform for patients with stroke will be conducted through a crossover trial comparing three excitatory HD-tES waveforms for enhancing affected brain activity and three inhibitory HD-tES waveforms for reducing activity in the unaffected hemisphere Changes in cortical excitability over a 2-hour period before and after stimulation will be monitored
2 Exploration of the Effects of Unilateral and Bilateral HD-tES in Patients with Subacute Stroke A triple-blind randomized controlled trial will be conducted to compare four neuromodulatory modes combined with conventional upper limb rehabilitation on brain activity and upper limb function in patients with subacute stroke These modes include excitatory stimulation on the affected hemisphere based on results from sub-project one choosing from aDC iTBS or aDCiTBS inhibitory stimulation on the unaffected hemisphere based on results from sub-project one choosing from cDC cTBS or cDCcTBS simultaneous bilateral stimulation and sham stimulation
The primary outcome will focus on upper limb functional activity and upper limb motor function with other indicators serving as secondary outcomes
1 Investigation of Neuromodulatory Effects of Stimulation Waveforms and Optimal Stimulation Waveform for Patients with Stroke a crossover trial will compare the effects of seven high-definition transcranial electrical stimulation HD-tES waveforms on neural excitatory or inhibitory activity in healthy adults These waveforms include three excitatory wave forms anodal direct current aDC intermittent theta burst stimulation iTBS and a combination of aDC and iTBS aDCiTBS and three inhibitory wave forms cathodal direct current cDC continuous theta burst stimulation cTBS and a combination of cDC and cTBS cDCcTBS along with a sham stimulation condition Changes in cortical excitability over a 2-hour period before and after stimulation will be tracked
Validation of the optimal stimulation waveform for patients with stroke will be conducted through a crossover trial comparing three excitatory HD-tES waveforms for enhancing affected brain activity and three inhibitory HD-tES waveforms for reducing activity in the unaffected hemisphere Changes in cortical excitability over a 2-hour period before and after stimulation will be monitored
2 Exploration of the Effects of Unilateral and Bilateral HD-tES in Patients with Subacute Stroke A triple-blind randomized controlled trial will be conducted to compare four neuromodulatory modes combined with conventional upper limb rehabilitation on brain activity and upper limb function in patients with subacute stroke These modes include excitatory stimulation on the affected hemisphere based on results from sub-project one choosing from aDC iTBS or aDCiTBS inhibitory stimulation on the unaffected hemisphere based on results from sub-project one choosing from cDC cTBS or cDCcTBS simultaneous bilateral stimulation and sham stimulation
The primary outcome will focus on upper limb functional activity and upper limb motor function with other indicators serving as secondary outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None