Effects of Intermitted Theta Burst Stimulation (iTBS) on Motor Recovery of Upper Extremity in Chronic Stroke Patients (NIMBLE)

Danderyd Hospital

Status: Enrolling

Conditions: Stroke; Chronic Stroke Patients; Hand Functionality; Hemiparesis After Stroke; Hemiplegia

Treatments: Device: Sham Intermittent Theta Burst Stimulation; Device: Intermittent Theta Burst Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07073248

iTBS-study upper extremity

Details and patient eligibility

About

This study aims to evaluate the effects and clinical feasibility of non-invasive brain stimulation protocols, specifically intermittent Theta Burst Stimulation, as part of rehabilitation interventions for motor recovery of upper extremity in the chronic phase after stroke.

It also seeks to explore the underlying mechanisms by investigating changes of functional and structural brain networks.

Full description

In this randomized controlled trial (RCT) group A will receive iTBS while group B will receive sham iTBS. Both groups will directly after the intervention receive 45 minutes of conventional physical therapy 3 times per week for 5 weeks, a total of 15 interventions by a blinded physiotherapist. For the iTBS intervention a Magstim Rapid² stimulator will be used also equipped with a Cadwell Sierra Summit EMG system [for motor evoked potential (MEP) measurements] and an ANT Visor2™ neuronavigation system [for navigated transcranial magnetic stimulation (TMS) interventions]. The iTBS parameters that will be used are: 600 pulses under 190 seconds at 80 % of Active Motor Threshold (AMT). The ipsilesional motor cortex will be targeted. The participants and clinical assessors will be blinded to the intervention.

All the patients will undergo advanced neuroimaging examinations before and after the intervention period. The exams will be then compared to identify neuroplastic changes in brain circuits.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18
• Chronic stroke (>6 months)
• Residual hemiparesis FM-UE>17

Exclusion criteria

• Metal implants
• Epilepsy/seizures
• Pregnancy
• Claustrophobia (related to MRIs exams)
• Severe cognitive impairment
• Untreated or unstable depression/anxiety
• Other disabilities prohibiting intensive physical training

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

Ipsilesional motor cortex iTBS and conventional rehabilitation

Experimental group

Description:

The experimental group will receive intermittent theta burst stimulation on the ipsilesional motor cortex followed by 45 minutes of conventional rehabilitation interventions involving the upper extremity led or instructed by a physiotherapist.

Treatment:

Device: Intermittent Theta Burst Stimulation

Ipsilesional motor cortex sham-iTBS and conventional rehabilitation

Sham Comparator group

Description:

The placebo group will receive sham intermittent theta burst stimulation on the ipsilesional motor cortex followed by 45 minutes of conventional rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist.

Treatment:

Device: Sham Intermittent Theta Burst Stimulation