RECRUITING

Mechanisms of Open and Hidden Placebo in Stroke Recovery

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanisms of Open and Hidden Placebo in Stroke Recovery

Quick Facts

Study Start:2023-09-11

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05832567

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults with hemiparesis due to chronic stroke 2. Stroke duration of 6 months or more 3. Fugl-Meyer scale upper extremity motor assessment score of \> 11 and ≤ 56 4. Pre-stroke disability (defined as a score of \< 3 on the Modified Rankin Scale) 5. Age 18 or older	1. Stroke of anterior cerebral artery territory with prefrontal lesion and stroke-related decreased EEG power in the prefrontal cortex 2. Unable to understand instructions 3. TMS contraindications: electronic hardware in close contact to the discharging coil such as cochlear implant, internal pulse generator or medical pump 4. Concurrent unstable medical conditions 5. A score of 24 or higher on the Hamilton Depression Rating Scale (HDRS) 6. Joint or paretic extremity pain likely to interfere with assessments 7. Pregnancy

Inclusion Criteria

Exclusion Criteria

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

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

Contacts and Locations

Study Contact

Felipe Fregni, MD, PhD, MPH

CONTACT

6179526156

fregni.felipe@mgh.harvard.edu

Elly Pichardo, MD

CONTACT

6179526154

epichardo@partners.org

Principal Investigator

Felipe Fregni, MD, PhD, MPH

PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital/Harvard Medical School

Study Locations (Sites)

Spaulding Hospital Cambridge

Cambridge, Massachusetts, 02138

United States

Collaborators and Investigators

Sponsor: Spaulding Rehabilitation Hospital

Felipe Fregni, MD, PhD, MPH, PRINCIPAL_INVESTIGATOR, Spaulding Rehabilitation Hospital/Harvard Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-11

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-09-11

Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

stroke
placebo

Additional Relevant MeSH Terms

Stroke
Hemiparesis