Mechanisms of Open and Hidden Placebo in Stroke Recovery

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT05832567
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active rTMS — DEVICE
    Subjects will undergo repetitive transcranial magnetic stimulation, each session lasting 20 minutes.
  • Sham rTMS — DEVICE
    Subjects will undergo sham repetitive transcranial magnetic stimulation, each session lasting 20 minutes.
  • Open Placebo — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

Start date
Sep 11, 2023
Status verified
Sep 2025
Primary completion
Jun 1, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Active rTMS
    The participant will receive a session of low frequency rTMS to the contralesional primary motor cortex. Low frequency rTMS stimulation will be applied according to the following parameter: intensity of 80% MT (intensity could be adjusted if not comfortable to the subject), frequency of 1 Hz, 1200 pulses as a single, continuous train lasting 20 minutes.
  • Sham Comparator: Sham rTMS
    The investigators will place the coil in the same location, usually used for the active stimulation with the same stimulation parameters. However, the investigators will replace the active coil with a sham coil to ensure no stimulation is provided.
  • Placebo Comparator: Open Placebo
    The open placebo will consist of typical prescription medicine bottle of placebo pills with a label clearly marked "placebo pills" "take 2 pills twice daily." The placebo pills are made from Microcrystalline Cellulose.
  • No Intervention: No Intervention
    It consists of treatment-as-usual group.

Primary Outcome Measure

Electroencephalography (EEG): Frontal alpha asymmetry [ Time Frame: Change from 2 weeks to baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Spaulding Hospital CambridgeCambridgeMassachusetts02138
Elly Pichardo, MD
[email protected]
617-952-6158
Felipe Fregni, MD, PhD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cambridge, MA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Spaulding Hospital Cambridge· Cambridge, MA

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