Mechanisms of Open and Hidden Placebo in Stroke Recovery

Stroke Clinical Trial

Official title: Mechanisms of Open and Hidden Placebo in Stroke Recovery

Status Recruiting

Clinical Trial Summary

This trial aims to investigate whether placebo in isolation (open and hidden) has a specific neural signature in stroke subjects thus providing a novel mechanism to explain placebo effects that can be used to ultimately enhance stroke rehabilitation therapies.

Clinical Trial Description

Placebo effect leads to significant effects on brain excitability and connectivity, ultimately influencing clinical outcomes, including motor learning in stroke. This trial will provide critical mechanistic data to improve the understanding of placebo in stroke clinical trials, as to solve methodological and ethical dilemma in research designs, and to improve its clinical outcomes. It aims to investigate whether placebo in isolation (open and hidden) has a specific neural signature in stroke subjects. For this purpose, the investigators plan to recruit 56 chronic stroke participants, that will be randomized using blocked randomization in a 2:2:2:1 proportion to one of the following groups, respectively: 1) open placebo (OP) alone (16 subjects); 2) sham rTMS alone (16 subjects); 3) no intervention (16 subjects); or 4) active rTMS alone (8 subjects). All four groups will undergo 2 weeks of daily intervention visits (10 sessions). ;

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

• NCT number: NCT05832567
• Study type: Interventional
• Source: Spaulding Rehabilitation Hospital
• Contact: Felipe Fregni, MD, PhD, MPH
• Phone: 6179526156
• Email: fregni.felipe@mgh.harvard.edu
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Completion date: June 30, 2025