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

NCT07792811 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NIMBUS
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Stroke Assessment

Keywords

Stroke Rehabilitation; Upper Extremity Motor Recovery; Noninvasive Brain Stimulation; Transcranial electrical temporal interference stimulation (tTIS); Neuroplasticity; Personalized medicine; Randomized controlled trial

Outcome Measures

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.

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

Secondary Outcomes (37)

• Change in Barthel Index Score

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

• Changes in daily life-oriented behavior - Questionnaires.

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

• Change in Modified Rankin Scale Score

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

• Change in Functional Independence Measure Total Score

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

• Change in Modified Upper Limb Lucerne ICF-Based Multidisciplinary Observation Scale Score

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

Study Arms (2)

Experimental: Active iTBS-tTIS Striatum + Rehabilitation

EXPERIMENTAL

Participants receive personalized, non-invasive deep brain stimulation targeting the striatum using transcranial electrical temporal interference stimulation (tTIS) combined with intermittent theta-burst stimulation (iTBS). Stimulation is delivered via individually positioned electrodes based on each participant's brain anatomy, concurrently with intensive upper-limb rehabilitation training (3 sessions per day for 1 week).

Device: Non-invasive transcranial Temporal Interference Stimulation (iTBS-tTIS Striatum); Behavioral: Concurrent Intensive Motor Rehabilitation

Active Comparator: Sham tTIS Striatum + Rehabilitation

ACTIVE COMPARATOR

Participants receive sham (inactive) transcranial electrical temporal interference stimulation targeting the striatum, delivered with identical setup and procedures as the active condition but without effective stimulation. This is combined with the same intensive upper-limb rehabilitation training protocol (3 sessions per day for 1 week).

Behavioral: Concurrent Intensive Motor Rehabilitation; Device: Non-invasive transcranial Temporal Interference Stimulation sham-tTIS Striatum)

Interventions

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.

Experimental: Active iTBS-tTIS Striatum + Rehabilitation

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.

Active Comparator: Sham tTIS Striatum + Rehabilitation; Experimental: Active iTBS-tTIS Striatum + Rehabilitation

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.

Active Comparator: Sham tTIS Striatum + Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• a. 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.
• ii. 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.
• iv. Surface-mounted conductive objects: conductive low-impedance structure mounted to the skin that may introduce shortcuts.
• c. History of seizures d. Medication that significantly interacts with NIBS being benzodiazepines, tricyclic antidepressants and antipsychotics.
• e. Non-intact skin where electrodes are intended ot be placed
• Pregnancy
• Regular use of narcotic drugs or abusive alcohol consumption
• Integral and bilateral lesion of the striatum
• Concomittant participation in another clinical trial
• Active request of not being informed in case of incidental findings

Sponsors & Collaborators

• Friedhelm Hummel: lead
• Luzerner Kantonsspital: collaborator
• Hôpitaux Universitaires Genève: collaborator

Study Sites (1)

CRR SUVA

Sion, Valais, 1951, Switzerland

Location

Related Links

• Website of the Clinical Trial

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Friedhelm C. Hummel, Prof. Dr.

  Ecole Polytechnique Fédérale de Lausanne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmina P. Paneva, Dr.

CONTACT

+41772652660; jasmina.paneva@epfl.ch

Camille Proulx, Dr.

CONTACT

camille.proulx@epfl.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a quadruple-blind study in which participants, care providers, investigators, and outcomes assessors are blinded to treatment allocation. Participants are randomized to receive either active stimulation or sham stimulation. The sham procedure mimics the active intervention in setup and sensation but does not deliver effective stimulation. Treatment allocation is concealed using coded conditions, and stimulation parameters are pre-programmed to ensure that study personnel administering the intervention remain unaware of group assignment. Blinding is maintained throughout the study, and outcome assessments are conducted by personnel who are not involved in treatment delivery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor, Director Defitech Chair of Clinical Neuroengineering

Model Details: Randomised; placebo-controlled; parallel; quadruple-blind; multicentric

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 13, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

CH (1)