SSRIs and TDCS Enhance Post-stroke Motor Recovery

Stroke Clinical Trial

Official title:

Combining SSRIs and TDCS to Enhance Motor Recovery After Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05041582
• Other study ID #: Co-STARS
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 1, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2021
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

This is a randomized, double-blind, sham-controlled study in 80 patients with first-ever, unilateral, subcortical ischemic stroke 0.5-4 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• aged 20-80;
• first-onset stroke
• brain image confirmed unilateral subcortical infarction
• moderate to severe upper-limb impairment (SAFE score <8).
• 3 days to 4 weeks after stroke onset
• stable medical condition

Exclusion Criteria:

• metal implants, such as electrodes or pacemaker
• epilepsy history or active spikes from EEG recording
• major depression or taking psychoactive drugs
• alcoholism or drug abuse history
• combined with other severe neurological or psychiatric diagnoses
• pregnancy or breastfeeding;
• other contraindications to brain MRI, such as severe claustrophobia
• intolerance to electrical stimulation

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• tDCS
dual tDCS with ipsilesional primary motor cortex (M1) anodal stimulation and contralesional M1 cathodal stimulation, 2 weeks after SSRI treatment

Drug:
• Citalopram
total 3 months, since 2-4 weeks after stroke

Behavioral:
• Rehabilitation
hospitalized rehabilitation, 3 hours daily

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Chih-Wei Tang	Taipei Veterans General Hospital, Taiwan, University of Oxford

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor scores 3 months after intervention	Motor scores include Action research arm test (0-66, higher scores mean a better outcome) and Fugl-Meyer Assessment (0-54, higher scores mean a better outcome)	3 months after intervention