Ignite Creation Date:
2024-05-06 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05041582
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-09-13
First Post:
2021-09-02
Brief Title:
SSRIs and TDCS Enhance Post-stroke Motor Recovery
Sponsor:
Chih-Wei Tang
Organization:
Far Eastern Memorial Hospital
Study Overview
Official Title:
Combining SSRIs and TDCS to Enhance Motor Recovery After Stroke
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-09
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:
Post-stroke motor recovery is compelling but limited Current rehabilitation has less impacts on the plateau that spontaneous biological recovery could be expected The advances in non-invasive neuromodulation and neurophysiological characterization of critical motor recovery period enable breaking the proportional recovery limitation Our pilot studies demonstrated the safety and responsiveness of combing dual transcranial direct current stimulation tDCS and motor training in subacute stroke patients There is also strong evidence that selective serotonin reuptake inhibitors SSRIs can substantially increase the effects of tDCS and improve motor function after stroke even in the absence of depression This proposal aims to prove the potential of combining of tDCS and the commonly used SSRI citalopram to improve response to a daily motor training intervention in acute stroke patients Co-STARS trial
Detailed Description:
This is a randomized double-blind sham-controlled study in 80 patients with first-ever unilateral subcortical ischemic stroke 05-4 weeks after stroke onset with moderate to severe hemiparesis Participants were randomized into four groups underwent either real dual tDCS ipsilesional primary motor cortex M1 anodal stimulation and contralesional M1 cathodal stimulation 2 mA for 20 mins 10 sessions within 2 weeks with citalopram or placebo or sham stimulation with citalopram or placebo All will receive concurrent hospitalized intensive rehabilitation of 2 daily sessions of 90-minute physiotherapy Action reach am test ARAT Fugl-Meyer Assessment FMA multimodality MRI and EEG will be measured at baseline and after 2 weeks tDCS modulation The primary outcome is the ARAT at 3 months after intervention The combination of tDCS and a SSRI will be expected to improve response to motor training more effectively than either intervention alone The enhanced responsiveness will be correlated or predicted by biomarkers from multimodality MRI or EEG
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