SSRIs and TDCS Enhance Post-stroke Motor Recovery

NCT05041582 | Unknown Phase 3 DMC

• 1 other identifier: Co-STARS
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Stroke; Motor

Keywords

stroke, motor recovery, transcranial direct current stimulation, selective serotonin reuptake inhibitors

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Real tDCS + Citalopram + Rehabilitation

EXPERIMENTAL

* Real tDCS, 2 mA for 20 mins per session, 10 sessions within 2 weeks * Citalopram 10mg oral intake daily for 3 months, since 2 weeks before tDCS

Device: tDCS; Drug: Citalopram; Behavioral: Rehabilitation

Sham tDCS + Citalopram + Rehabilitation

SHAM COMPARATOR

* Sham tDCS, ramped up over 10 seconds and then reduced to 0mA, 10 sessions within 2 weeks * Citalopram 10mg oral intake daily for 3 months, since 2 weeks before tDCS

Drug: Citalopram; Behavioral: Rehabilitation

Real tDCS + Placebo + Rehabilitation

PLACEBO COMPARATOR

* Real tDCS, 2 mA for 20 mins per session, 10 sessions within 2 weeks * Placebo oral intake daily for 3 months, since 2 weeks before tDCS

Device: tDCS; Behavioral: Rehabilitation

Sham tDCS + Placebo + Rehabilitation

PLACEBO COMPARATOR

* Sham tDCS, ramped up over 10 seconds and then reduced to 0mA, 10 sessions within 2 weeks * Placebo oral intake daily for 3 months, since 2 weeks before tDCS

Behavioral: Rehabilitation

Interventions

tDCS DEVICE

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

Real tDCS + Citalopram + Rehabilitation; Real tDCS + Placebo + Rehabilitation

Citalopram DRUG

total 3 months, since 2-4 weeks after stroke

Real tDCS + Citalopram + Rehabilitation; Sham tDCS + Citalopram + Rehabilitation

Rehabilitation BEHAVIORAL

hospitalized rehabilitation, 3 hours daily

Real tDCS + Citalopram + Rehabilitation; Real tDCS + Placebo + Rehabilitation; Sham tDCS + Citalopram + Rehabilitation; Sham tDCS + Placebo + Rehabilitation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chih-Wei Tang: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• University of Oxford: collaborator

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation; Citalopram; Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Stroke Center

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 13, 2021
• Study Start: September 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2025
• Last Updated: September 13, 2021

Record last verified: 2021-09