Deep Non-Invasive Brain Stimulation to Improve Arm Recovery After Stroke

Zusammenfassung der Studie

Every year, millions of people suffer from a stroke. Despite rehabilitation, more than one in two individuals continues to have difficulties moving their arm and hand, which significantly complicates daily life. The NIMBUS project aims to improve this situation by testing a new method of deep non-invasive brain stimulation to promote motor recovery after a stroke. Recovery after a stroke largely depends on the brain's ability to relearn. Research has shown that certain deep regions of the brain play a key role in this process. Until now, stimulating these areas required surgical intervention. An innovative technique called transcranial temporal interference stimulation allows targeting these deep regions without surgery, using electrodes placed on the scalp. This technique is very safe, painless, and does not cause unpleasant sensations. Stimulation will be applied during rehabilitation sessions to accompany exercises and enhance their effects. The clinical trial will include 84 patients who have had a stroke. Participants will be randomly assigned to two groups: one will receive active stimulation, while the other will receive inactive stimulation (placebo). Neither the patients, the healthcare team, nor the researchers will know which group each participant is in, to ensure reliable results. All will benefit from the same personalized rehabilitation program, conducted several times a day for a week. The main objective is to determine whether this stimulation, combined with rehabilitation, improves arm and hand recovery and facilitates daily living activities. This project was designed in close collaboration with patients, caregivers, and healthcare professionals to best meet the real needs of those affected.

(BASEC)

Untersuchte Intervention

The proposed intervention is based on an innovative and personalized strategy of non-invasive deep brain stimulation aimed at improving motor recovery of the upper limb in patients who have experienced a stroke in the chronic phase.

The technique used, called transcranial temporal interference stimulation (tTIS), selectively targets the striatum, a deep brain structure involved in motor learning and neural plasticity, without the need for surgical intervention. The stimulation is individualized for each patient based on their brain anatomy.

The applied stimulation corresponds to a specific protocol of intermittent theta burst stimulation (iTBS-tTIS), designed to enhance the neural plasticity properties of the striatum and thus potentiate the effects of intensive rehabilitation. Stimulation is delivered using four circular surface electrodes placed on the scalp, utilizing high-frequency, low-intensity alternating sinusoidal currents in conditions recognized as safe and painless.

Each stimulation session is conducted alongside a standardized 30-minute rehabilitation training, starting simultaneously with the stimulation. The goal is to maximize the effects of the stimulation by directly associating it with targeted functional exercises of the upper limb.

Participants are randomly assigned to receive either active stimulation or a placebo stimulation, where stimulation is briefly applied at the beginning and end of the session to reproduce initial sensations without neuromodulatory effect. This setup ensures that patients, therapists, evaluators, and caregivers are unaware of the type of stimulation applied (quadruple-blind trial).

The intervention is conducted by therapists three times a day, ideally on weekdays, over a period of one week, for a total of 15 sessions. Rehabilitation is guided by a standardized manual, and all therapists and investigators undergo specific training to ensure the homogeneity of procedures, stimulation, and evaluations.

This combined approach aims to enhance the effects of intensive rehabilitation by selectively modulating the deep brain networks involved in motor recovery after a stroke, while ensuring a high level of safety, standardization, and methodological rigor.

(BASEC)

Untersuchte Krankheit(en)

Stroke

(BASEC)

Sponsor

Ecole Polytechnique Fédérale de Lausanne

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Waadt

(BASEC)

Datum der Bewilligung durch die Ethikkommission

02.03.2026

(BASEC)

Ergebnisse der Studie