RecruitingNot ApplicableNCT05832567

Mechanisms of Open and Hidden Placebo in Stroke Recovery


Sponsor

Spaulding Rehabilitation Hospital

Enrollment

56 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Adults with hemiparesis due to chronic stroke
  • Stroke duration of 6 months or more
  • Fugl-Meyer scale upper extremity motor assessment score of \> 11 and ≤ 56
  • Pre-stroke disability (defined as a score of \< 3 on the Modified Rankin Scale)
  • Age 18 or older

Exclusion Criteria7

  • Stroke of anterior cerebral artery territory with prefrontal lesion and stroke-related decreased EEG power in the prefrontal cortex
  • Unable to understand instructions
  • TMS contraindications: electronic hardware in close contact to the discharging coil such as cochlear implant, internal pulse generator or medical pump
  • Concurrent unstable medical conditions
  • A score of 24 or higher on the Hamilton Depression Rating Scale (HDRS)
  • Joint or paretic extremity pain likely to interfere with assessments
  • Pregnancy

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Interventions

DEVICEActive rTMS

Subjects will undergo repetitive transcranial magnetic stimulation, each session lasting 20 minutes.

DEVICESham rTMS

Subjects will undergo sham repetitive transcranial magnetic stimulation, each session lasting 20 minutes.

DIETARY_SUPPLEMENTOpen Placebo

The open placebo will consist of an inactive substance pill commonly used in clinical trials and given to the subject in a regular pill dispenser.


Locations(1)

Spaulding Hospital Cambridge

Cambridge, Massachusetts, United States

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NCT05832567


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