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

ConditionsStrokeStroke Assessment
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFriedhelm Hummel

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Informed Consent signed by the participant

Age ≥ 18 years old

First ever ischemic stroke with motor impairment

Stroke incident ≥ 12 weeks at consent

Disqualifiers

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)

Severe cognitive, sensory or musculoskeletal dysfunctions prohibiting to understand instructions or to perform the rehabilitative tasks

Contraindications for NIBS or MRI

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non-invasive transcranial Temporal Interference Stimulation (iTBS-tTIS Striatum)

    Device

    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

    Behavioral

    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)

    Device

    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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Experimental: Active iTBS-tTIS Striatum + RehabilitationExperimental treatment 2 interventions
Group B: Active Comparator: Sham tTIS Striatum + RehabilitationActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in Upper-Limb Motor Function (Composite Motor Score)

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.

Time frame
Baseline (Week 1), post-intervention (Week 3, ±3 days), and follow-up (Week 14, ±10 days)

Secondary outcomes

1

Change in Barthel Index Score

Independence in basic activities of daily living will be assessed using the Barthel Index. The instrument evaluates feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers, mobility, and stair use. The total score ranges from 0 to 100, with higher scores indicating greater independence. The outcome will be the change in total score from baseline to post-intervention and follow-up.

Time frame
Baseline (Week 1), post-intervention (Week 3, ±3 days), and follow-up (Week 14, ±10 days)
2

Changes in daily life-oriented behavior - Questionnaires.

Changes in daily functioning and perceived health will be evaluated from before the therapy (week 1) to after the therapy (week 3) using validated clinical questionnaires and observation scales. Outcomes will include: change in independence in activities of daily living, change in upper-limb performance during daily activities, change in patient-reported global health and well-being.

Time frame
Baseline (Week 1), post-intervention (Week 3, ±3 days), and follow-up (Week 14, ±10 days)
3

Change in Modified Rankin Scale Score

Global disability will be assessed using the Modified Rankin Scale. Scores range from 0 to 5 in the study CRF, with 0 indicating no symptoms and 5 indicating severe disability requiring constant nursing care and attention. The outcome will be the change in score from baseline to post-intervention and follow-up.

Time frame
Baseline (Week 1), post-intervention (Week 3, ±3 days), and follow-up (Week 14, ±10 days)
4

Change in Functional Independence Measure Total Score

Functional independence will be assessed using the Functional Independence Measure (FIM), covering self-care, sphincter control, transfers, locomotion, communication, and social cognition. Individual items are rated from 1 (total assistance) to 7 (complete independence), and the total FIM score will be used as the outcome measure. Higher scores indicate greater functional independence. The outcome will be the change in total score from baseline to post-intervention and follow-up.

Time frame
Baseline (Week 1) and post-intervention (Week 3, ±3 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Friedhelm Hummel

Lead sponsor

Ecole Polytechnique Fédérale de Lausanne

Sponsor institution

Luzerner Kantonsspital

Collaborator

Hôpitaux Universitaires Genève

Collaborator

Source ClinicalTrials.gov

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