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

Condition(s) studied

Investigational drug(s) / intervention(s)

Non-invasive transcranial Temporal Interference Stimulation (iTBS-tTIS Striatum): Transcranial Temporal Interference Stimulation (tTIS) is a non-invasive neuromodulation technique that applies multiple high-frequency electrical currents via scalp electrodes to generate an amplitude-modulated electric field in deep brain regions without surgery. The technique allows targeting of different deep brain structures depending on electrode configuration and current parameters. In this study, stimulation is individualized to target the striatum using subject-specific electrode placement based on anatomical information. The stimulation is delivered in a theta-burst-patterned protocol designed to induce plasticity-related effects. tTIS is applied concurrently with upper-limb rehabilitative training during each session. The intervention is administered over five consecutive days, with three sessions per day within an accelerated protocol.

Concurrent Intensive Motor Rehabilitation: Participants undergo intensive, task-oriented upper-limb rehabilitation training focused on improving motor function of the affected arm and hand following stroke. Training is delivered in a structured and personalized manner, adapted to the participant's level of impairment and functional capacity. Each session includes approximately 30 minutes of physiotherapy involving repetitive, goal-directed movements and functional tasks targeting upper-limb use. The rehabilitation is provided concurrently with stimulation (active or sham) and follows an accelerated schedule of three sessions per day over five consecutive days.

Non-invasive transcranial Temporal Interference Stimulation sham-tTIS Striatum): Sham Transcranial Temporal Interference Stimulation (tTIS) is a non-invasive neuromodulation procedure that applies two identical high-frequency electrical currents via scalp electrodes. Because the currents have the same frequency, no low-frequency amplitude-modulated electric field is generated in deep brain regions. The sham stimulation uses the same individualized electrode placement based on anatomical information and follows the same stimulation schedule and device settings as the active intervention, while not delivering the temporal interference pattern intended to modulate striatal activity. Sham tTIS is applied concurrently with upper-limb rehabilitative training during each session. The intervention is administered over five consecutive days, with three sessions per day within an accelerated protocol.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Upper-Limb Motor Function (Composite Motor Score) — Baseline (Week 1), post-intervention (Week 3, ±3 days), and follow-up (Week 14, ±10 days)
  Upper-limb motor performance assessed using a composite motor score including the Fugl-Meyer Assessment Upper Limb, Pinch \& Grip, Box\&Blocks, Nine-Hole Peg Test, and Action Research Arm Test (ARAT). The primary endpoint is defined as the change from baseline to post-intervention.

Trial sites (1)

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