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NCT05381740
A Novel Brain Stimulation for Bimanual Motor Function and Control in Chronic Stroke
EARLY_PHASE1 trial testing Novel rTMS Approach in Stroke in 17 participants. Completed in 1 January 2024.
6 December 2023
Quick facts
| Lead sponsor | The Cleveland Clinic |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 17 |
| Start date | 8 March 2022 |
| Primary completion | 6 December 2023 |
| Estimated completion | 1 January 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Novel rTMS Approach
- Sham rTMS Approach
Conditions studied
- Stroke — all drugs for Stroke →
Sponsor
The Cleveland Clinic
Who can join
Adults 18 to 90, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The long-term goal of this project is to develop and test upper Iimb rehabilitation interventions that can improve bimanual motor function, or the ability to use both arms and hands together, for stroke survivors with moderate to severe impairment. This study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 12 visits over a period of 6 weeks. The study will include the following site visits: * Eligibility Screening and Informed Consent Visit * Baseline testing (4 visits total): 1 visit each for MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs * Repeat baseline testing (4 visits total) of MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs * 12 intervention visits during which patients will receive upper limb therapy in conjunction with non-invasive brain stimulation * Repeat testing (4 visits total) of MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs * A follow-up visit 1 month after the completion of interventions
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05381740
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05381740 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Cleveland Clinic
- Last refreshed: 3 June 2024
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/NCT05381740.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing