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

NCT07073235 | Recruiting

• 1 other identifier: iTBS-study lower extremity
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke; Hemiparesis After Stroke; Chronic Stroke Patients; Hemiplegia; Ambulatory Difficulty

Keywords

stroke; iTBS; TMS; Trancranial Magnetic Stimulation; Cerebellum; Chronic stroke patients; Balance; Walking; Hemiparesis; intermittent Theta Burst Stimulation

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (14)

• Fugl-Meyer Assessment - Lower Extremity

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

• Modified Ashworth Scale (MAS)

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

• Neuroflexor

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

• Lower Extremity Motor Coordination Test (LEMOCOT)

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

• 6 minutes walk test

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

Other Outcomes (3)

• National Institutes of Health Stroke Scale (NIHSS)

  At baseline.

• Barthel Index (BI)

  At baseline.

• Theoretical Framework of Acceptability questionnaire

  After completion of the 5 week intervention to assess acceptability.

Study Arms (2)

Contralesional cerebellum iTBS and conventional rehabilitation

EXPERIMENTAL

The 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.

Device: Intermittent Theta Burst Stimulation

Contralesional cerebellum sham-iTBS and conventional rehabilitation

SHAM COMPARATOR

The 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.

Device: Sham Intermittent Theta Burst Stimulation

Interventions

Intermittent Theta Burst Stimulation DEVICE

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

Also known as: iTBS, TMS

Contralesional cerebellum iTBS and conventional rehabilitation

Sham Intermittent Theta Burst Stimulation DEVICE

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

Contralesional cerebellum sham-iTBS and conventional rehabilitation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Danderyd Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

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

Stockholm, Sweden

RECRUITING

Related Publications (10)

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

  PMID: 16791141 BACKGROUND

• 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.

  PMID: 38879485 BACKGROUND

• 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.

  PMID: 38426021 BACKGROUND

• 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.

  PMID: 30476999 BACKGROUND

• 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.

  PMID: 38297193 BACKGROUND

• 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.

  PMID: 34539362 BACKGROUND

• 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.

  PMID: 25034472 BACKGROUND

• 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.

  PMID: 30939100 BACKGROUND

• 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.

  PMID: 36437474 BACKGROUND

• 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.

  PMID: 36426136 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemiplegia; Mobility Limitation; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susanne Palmcrantz, PhD, Associate Professor

  Dep of Clinical Sciences, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Palmcrantz, PhD, Associate Professor

CONTACT

004681235000; susanne.palmcrantz@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate Professor, Reg Physiotherapist

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: November 25, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)