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

NCT07073248 | Recruiting

• 1 other identifier: iTBS-study upper extremity
• Study Type: interventional
• Target: 48
• 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 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.

Conditions

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

Keywords

stroke; iTBS; TMS; Motor cortex; chronic stroke patients; hand dexterity; Hemiparesis; Transcrania Magnetic Stimulation; intermittent Theta Burst Stimulation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment - Upper Extremity

  used to quantify recovery of sensorimotor function in the upper extremity after a stroke. It is a 63 item test scored on a 3-level ordinal scale. The score ranges from 0 to 126 points. A higher score indicates recovery of sensorimotor function.

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

Secondary Outcomes (14)

• 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.

• Box and Block Test (BBT)

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

• Action Research Arm Test (ARAT)

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

• Dextrain Manipulandum™

  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)

Ipsilesional motor cortex iTBS and conventional rehabilitation

EXPERIMENTAL

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.

Device: Intermittent Theta Burst Stimulation

Ipsilesional motor cortex sham-iTBS and conventional rehabilitation

SHAM COMPARATOR

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.

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 ipsilesional motor cortex, targeted with the support of a neuronavigational system, 15 sessions over a period of 5 weeks

Also known as: iTBS, TMS

Ipsilesional motor cortex 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

Ipsilesional motor cortex 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 FM-UE\>17

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

Stockholm, Sweden

RECRUITING

Related Publications (8)

• Lemon RN. Descending pathways in motor control. Annu Rev Neurosci. 2008;31:195-218. doi: 10.1146/annurev.neuro.31.060407.125547.

  PMID: 18558853 BACKGROUND

• Zhang JJ, Bai Z, Fong KNK. Priming Intermittent Theta Burst Stimulation for Hemiparetic Upper Limb After Stroke: A Randomized Controlled Trial. Stroke. 2022 Jul;53(7):2171-2181. doi: 10.1161/STROKEAHA.121.037870. Epub 2022 Mar 23.

  PMID: 35317611 BACKGROUND

• Zhang JJ, Sui Y, Sack AT, Bai Z, Kwong PWH, Sanchez Vidana DI, Xiong L, Fong KNK. Theta burst stimulation for enhancing upper extremity motor functions after stroke: a systematic review of clinical and mechanistic evidence. Rev Neurosci. 2024 Apr 29;35(6):679-695. doi: 10.1515/revneuro-2024-0030. Print 2024 Aug 27.

  PMID: 38671584 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

• van Lieshout ECC, van der Worp HB, Visser-Meily JMA, Dijkhuizen RM. Timing of Repetitive Transcranial Magnetic Stimulation Onset for Upper Limb Function After Stroke: A Systematic Review and Meta-Analysis. Front Neurol. 2019 Dec 3;10:1269. doi: 10.3389/fneur.2019.01269. eCollection 2019.

  PMID: 31849827 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

• 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

MeSH Terms

Conditions

Stroke; Hemiplegia; 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 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)