Recruiting

Placebo

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT05832567

Conditions

Stroke

Hemiparesis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active rTMS

Sham rTMS

Open Placebo

Study Details

Brief 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.

Conditions

Stroke

Hemiparesis

Study ID

NCT05832567

Start date

Sep 11, 2023

Status verified date

Jul, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Jun 1, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Active rTMS

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

Sham rTMS

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

Open 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Felipe Fregni, MD, PhD, MPH

6179526156fregni.felipe@mgh.harvard.edu

Elly Pichardo, MD

6179526154epichardo@partners.org

Locations

Spaulding Hospital Cambridge

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Elly Pichardo, MD

617-952-6158epichardo@partners.org

Principal Investigator:

Felipe Fregni, MD, PhD, MPH

More Information

Sponsor

Spaulding Rehabilitation Hospital

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • stroke
  • placebo

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital on 2026-07-14.