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NCT04672044

TMS and Exercise for Post-stroke Pain

Completed Phase 1 Results posted Last updated 15 June 2025
What this trial tests

Phase 1 trial testing Active rTMS and exercise in Chronic Post-stroke Headache in 9 participants. Completed in 30 December 2024.

Timeline
14 January 2022
Primary endpoint
30 December 2024
30 December 2024

Quick facts

Lead sponsorVA Office of Research and Development
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment9
Start date14 January 2022
Primary completion30 December 2024
Estimated completion30 December 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

19 and older, any sex, with Chronic Post-stroke Headache. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Modified Rankin Scale From Baseline to Follow-up 30 Days After Last Intervention Primary · From baseline to follow-up 30 days after last intervention

The modified Ranking scale (mRS) is a single-item, global, Likert-type scale ranging from 0-6 (higher scores mean a worse outcome) to categorize level of functional independence with comparison to pre-stroke function, accounting for activities of daily living. Participants were scored at baseline and 30 days after last intervention.

GroupValue95% CI
Active rTMS+Exercise0± 0
Sham rTMS+Exercise1± 1.41

Sponsor's own description

There are over 7 million people living with stroke in the United States. Per year, approximately 17,000 Veterans are admitted to the VA for acute stroke. Chronic pain after stroke can occur between 10-50% of stroke survivors. Post-stroke pain (PSP) can lead to further complications in a stroke survivor's recovery. Exercise has improved PSP and associated symptoms such as mobility, fatigue, and quality of life. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique using electromagnetic induction for cortical neurostimulation. The use of rTMS has been explored shown to be effective in treating chronic PSP but is limited in effect duration. Our proposal will test the hypothesis that rTMS is feasible and safe to be paired with exercise. Additionally, the investigators believe a complementary effect can develop to enhance the neurostimulation duration of rTMS.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The safety and feasibility of a pilot randomized clinical trial using combined exercise and neurostimulation for post-stroke pain: the EXERT-Stroke study.
    Lin C, Morgan CJ, Fortenberry ELS, Androulakis XM, et al · · 2025 · PMID 40343185 · DOI 10.3389/fneur.2025.1524004

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04672044.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing