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StrokeNIMBLENCT07073235

Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Lower Extremity in Chronic Stroke Patients

A study testing Intermittent Theta Burst Stimulation in people with Stroke and Hemiparesis After Stroke, run by Danderyd Hospital at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 lower extremity in the chronic phase after stroke. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intermittent Theta Burst Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteSweden
Study dates
Nov 2025to Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 18
  • Chronic stroke (>6 months)
  • Residual hemiparesis FAC ≥3

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Susanne Palmcrantz, PhD, Associate Professor contact

004681235000

susanne.palmcrantz@ki.se

Sweden1 site, 1 recruiting

  • Department of Rehabilitation Medicine, Danderyd Hospital, Danderyd, Stockholm 18288

    Stockholm

    Susanne Palmcrantz, PhD, 004681235000, susanne.palmcrantz@ki.se

    Recruiting

Other trials in Sweden

About this study

Official title: Neuroplastic Changes and Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Upper and Lower Extremity in Chronic Stroke Patients

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 lower extremity in the chronic phase after stroke.

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

Read the detailed description

In this randomized control 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 contralesional cerebellum 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.

Being tested
Intermittent Theta Burst Stimulation, Sham Intermittent Theta Burst Stimulation
Keywords
stroke, iTBS, TMS, Trancranial Magnetic Stimulation, Cerebellum, Chronic stroke patients, Balance, Walking, Hemiparesis, intermittent Theta Burst Stimulation
Medical subject headings
Stroke, Hemiplegia, Mobility Limitation, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intermittent Theta Burst StimulationDevice

    Also called iTBS, TMS

    iTBS protocol: 600 pulses at 80% of AMT for 190 sec on the contralesional cerebellum, targeted with the support of a neuronavigational system, 15 sessions over a period of 5 weeks

  • Sham Intermittent Theta Burst StimulationDevice

    It is identical to its active version, replicates operational sounds, and delivers a very shallow magnetic field to mimic the sensation of magnetic stimulation.

Study groups in NCT07073235
Study groupRoleWhat they receive
Contralesional cerebellum iTBS and conventional rehabilitationExperimentalThe experimental group will receive intermittent theta burst stimulation on the contralesional cerebellum followed by 45 minutes of conventional rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist.
Receives: Device: Intermittent Theta Burst Stimulation
Contralesional cerebellum sham-iTBS and conventional rehabilitationSham comparatorThe placebo group will get sham intermittent theta burst stimulation on the contralesional cerebellum followed by 45 minutes of conventional rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist.
Receives: Device: Sham Intermittent Theta Burst Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. miniBest test

    measures dynamic balance, functional mobility, and gait. It is a 14-item test scored on a 3-level ordinal scale. The score ranges from 0 to 28 points. A higher score indicates better balance.

    Measured: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.

Secondary outcomes (14)

  1. Fugl-Meyer Assessment - Lower Extremity

    used to quantify sensorimotor function recovery after a stroke. It is a 43 item test scored on a 3-level ordinal scale. The score ranges from 0 to 86 points. A higher score indicates higher sensorimotor recovery.

    Measured: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.

  2. Modified Ashworth Scale (MAS)

    Assesses spasticity on a 6 point scale/muscle (0p no impairment, 5p max impairment/muscle).

    Measured: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.

  3. Neuroflexor

    Medical technology device. Assesses spasticity by identifying the neural, viscous and elastic components during passive movement using a biomechanical algorithm (presented in Newton)

    Measured: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.

  4. Lower Extremity Motor Coordination Test (LEMOCOT)

    assesses motor coordination deficits after stroke. The LEMOCOT assesses how many times a participant can alternately touch a proximal and distal target with their big toe within 20 seconds. Higher scores indicate better motor coordination in the lower extremity.

    Measured: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.

  5. 6 minutes walk test

    assess submaximal aerobic/functional walking capacity, community walking prediction. Assesses walking endurance in meters walked. Longer distances indicate better walking capacity.

    Measured: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.

  6. Functional Ambulation Categories (FAC)

    evaluates ambulation ability. It ranges from 0 to 5. Higher score indicates more independent ambulation.

    Measured: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.

  7. Falls Efficacy Scale Swedish version (FES-S)

    measure the level of concern about falling during social and physical activities inside and outside home. The total score ranges from 0 to 130. A higher total score on the FES-S indicates greater confidence in performing the activities without falling.

    Measured: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.

  8. Walking impact scale (MSWS-12 S)

    Assesses self-perceived limitations in walking. The score ranges from 12 to 60 (12p no impairments, 60p max impairment).

    Measured: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.

  9. Canadian Occupational Performance Measure

    Captures the participant´s perception of performance in everyday living, over time and is used to set and evaluate goals of an intervention

    Measured: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.

  10. Montreal Cognitive Assessment (MoCA)

    Assesses mental function (0p max impairment summed up to 30p no detected impairment)

    Measured: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.

  11. Stroke Impact Scale (SIS)

    is a self-report questionnaire that evaluates disability and health-related quality of life after stroke. It has 8 domains: strength, hand function, mobility, physical and instrumental activities of daily living (ADL and IADL), memory and thinking, communication, emotion, and social participation. It uses a 5-point Likert scale to assess the difficulty of performing various tasks within each domain. Higher scores indicate better outcome

    Measured: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.

  12. Motor Evoked Potentials (MEPs)

    electrical signals recorded from neural tissue or muscle following activation of central motor pathways. MEPs assess the integrity of descending motor pathways.

    Measured: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.

  13. Resting state functional MRI (rs-fMRI)

    a method aimed at examining intrinsic networks in the brain while no task is performed (rest); this is to estimate correlations between brain regions.

    Measured: At baseline and after completion of the 5 week intervention to assess changes.

  14. Diffusion Tensor Imaging (DTI)

    a method aimed at mapping structural correlations between brain regions.

    Measured: At baseline and after completion of the 5 week intervention to assess changes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2025
  2. Study startNov 2025 (estimated)
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07073235
Sponsor's protocol ID
iTBS-study lower extremity
Acronym
NIMBLE
Status last verified
Aug 2025
First submitted
9 Jul 2025
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ramnani N. The primate cortico-cerebellar system: anatomy and function. Nat Rev Neurosci. 2006 Jul;7(7):511-22. doi: 10.1038/nrn1953.

    PubMed 16791141

  • Wang J, Wu Z, Hong S, Ye H, Zhang Y, Lin Q, Chen Z, Zheng L, Qin J. Cerebellar transcranial magnetic stimulation for improving balance capacity and activity of daily living in stroke patients: a systematic review and meta-analysis. BMC Neurol. 2024 Jun 15;24(1):205. doi: 10.1186/s12883-024-03720-1.

    PubMed 38879485

  • Wang C, Zhang Q, Zhang L, Zhao D, Xu Y, Liu Z, Wu C, Wu S, Yong M, Wu L. Comparative efficacy of different repetitive transcranial magnetic stimulation protocols for lower extremity motor function in stroke patients: a network meta-analysis. Front Neurosci. 2024 Feb 15;18:1352212. doi: 10.3389/fnins.2024.1352212. eCollection 2024.

    PubMed 38426021

  • Koch G, Bonni S, Casula EP, Iosa M, Paolucci S, Pellicciari MC, Cinnera AM, Ponzo V, Maiella M, Picazio S, Sallustio F, Caltagirone C. Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):170-178. doi: 10.1001/jamaneurol.2018.3639.

    PubMed 30476999

  • Jiang T, Wei X, Wang M, Xu J, Xia N, Lu M. Theta burst stimulation: what role does it play in stroke rehabilitation? A systematic review of the existing evidence. BMC Neurol. 2024 Feb 1;24(1):52. doi: 10.1186/s12883-023-03492-0.

    PubMed 38297193

  • Fan H, Song Y, Cen X, Yu P, Biro I, Gu Y. The Effect of Repetitive Transcranial Magnetic Stimulation on Lower-Limb Motor Ability in Stroke Patients: A Systematic Review. Front Hum Neurosci. 2021 Sep 1;15:620573. doi: 10.3389/fnhum.2021.620573. eCollection 2021.

    PubMed 34539362

  • Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.

    PubMed 25034472

  • Christiansen MG, Senko AW, Anikeeva P. Magnetic Strategies for Nervous System Control. Annu Rev Neurosci. 2019 Jul 8;42:271-293. doi: 10.1146/annurev-neuro-070918-050241. Epub 2019 Apr 2.

    PubMed 30939100

  • Qi S, Tian M, Rao Y, Sun C, Li X, Qiao J, Huang ZG. Applying transcranial magnetic stimulation to rehabilitation of poststroke lower extremity function and an improvement: Individual-target TMS. Wiley Interdiscip Rev Cogn Sci. 2023 Mar;14(2):e1636. doi: 10.1002/wcs.1636. Epub 2022 Nov 27.

    PubMed 36437474

  • Fan J, Fu H, Xie X, Zhong D, Li Y, Liu X, Zhang H, Zhang J, Huang J, Li J, Jin R, Zheng Z. The effectiveness and safety of repetitive transcranial magnetic stimulation on spasticity after upper motor neuron injury: A systematic review and meta-analysis. Front Neural Circuits. 2022 Nov 8;16:973561. doi: 10.3389/fncir.2022.973561. eCollection 2022.

    PubMed 36426136

Questions about this trial

What is this clinical trial studying?

A study testing Intermittent Theta Burst Stimulation in people with Stroke and Hemiparesis After Stroke, run by Danderyd Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Susanne Palmcrantz, PhD, Associate Professor (004681235000, susanne.palmcrantz@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

miniBest test (time frame: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07073235, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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