Non-Invasive Deep Brain Stimulation for Upper Limb Recovery After Stroke (NIMBUS)

Trial details

Who runs it

Friedhelm Hummel

Trial code

NCT07792811

Record updated

28 August 2026

Original description

NIMBUS is a clinical study evaluating a new, non-invasive brain stimulation treatment to improve arm and hand function in people with long-term effects of stroke. The treatment uses a personalized method to stimulate deeper areas of the brain through the scalp, without surgery, while participants undergo intensive physiotherapy rehabilitation. Physiotherapy in combination with the brain stimulation will occur three times a day over the course of a week. In the study, participants are randomly assigned to receive either the active treatment or a sham (inactive) version, so researchers can compare the outcomes fairly. The study will assess whether the treatment is safe, feasible, and effective by measuring changes in arm movement, daily activities, and brain function before and after the treatment. The goal is to determine whether this approach can enhance recovery after stroke and support the development of improved rehabilitation therapies.Read full original descriptionShow less

Non-Invasive neuroModulation of Deep Brain Structures for Upper Limb Recovery After Stroke by Transcranial Temporal Interference Electric Stimulation.

NIMBUS is a clinical study evaluating a new, non-invasive brain stimulation treatment to improve arm and hand function in people with long-term effects of stroke. The treatment uses a personalized method to stimulate deeper areas of the brain through the scalp, without surgery, while participants undergo intensive physiotherapy rehabilitation. Physiotherapy in combination with the brain stimulation will occur three times a day over the course of a week. In the study, participants are randomly assigned to receive either the active treatment or a sham (inactive) version, so researchers can compare the outcomes fairly. The study will assess whether the treatment is safe, feasible, and effective by measuring changes in arm movement, daily activities, and brain function before and after the treatment. The goal is to determine whether this approach can enhance recovery after stroke and support the development of improved rehabilitation therapies.

Inclusion: Informed Consent signed by the participant; Age ≥ 18 years old; First ever ischemic stroke with motor impairment; Stroke incident ≥ 12 weeks at consent; Moderate to severe motor impairment (Fugl-Meyer Assessment (FMA) >20 and <58).

Exclusion: Regular use of narcotic drugs or abusive alcohol consumption; Unable to provide informed consent due to cognitive, psychiatric, or medical conditions impairing decision-making capacity; Severe neuropsychiatric (e.g., major depression, schizophrenia) or medical disease (e.g., progressive cancer, unstable systemic disease, neurodegenerative disease); Contraindications for NIBS or MRI; Electronic or ferromagnetic medical implants/device, non-MRI compatible metal implant, b. Fully or partially implanted conductive objects i. Passive implants: stents, orthopedic/orthodontic implants, screws, shunts, etc; Active implants: cochlear implants, deep brain stimulation leads and electrodes, fully implanted brain monitoring devices iii. Partially implanted devices: monitoring electrodes (e.g., stereoelectroencephalography, electrocortigraphy, etc; Surface-mounted conductive objects: conductive low-impedance structure mounted to the skin that may introduce shortcuts; History of seizures d. Medication that significantly interacts with NIBS being benzodiazepines, tricyclic antidepressants and antipsychotics; Non-intact skin where electrodes are intended ot be placed; Severe cognitive, sensory or musculoskeletal dysfunctions prohibiting to understand instructions or to perform the rehabilitative tasks; Pregnancy; Integral and bilateral lesion of the striatum; Concomittant participation in another clinical trial; Active request of not being informed in case of incidental findings.

ClinicalTrials.gov NCT07792811