Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Post-Stroke Spasticity
NCT ID: NCT02268461
Last Updated: 2025-01-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
4 participants
INTERVENTIONAL
2014-12-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to determine whether patients with upper limb spasticity as a consequence of a chronic stroke can benefit from stimulation of the non-affected hemisphere of the brain with low-frequency (inhibitory) repetitive Transcranial Magnetic Stimulation (rTMS), potentially leading to a reduction of spasticity and clinical improvement in upper limb function.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Repetitive Transcranial Magnetic Stimulation Use in Acute Stroke
NCT01922986
Stroke Therapy With Brain Oscillation Synchronized Stimulation
NCT05005780
rTMS and Physical Therapy as a Clinical Service for People With Stroke
NCT02954211
The Effect of rTMS in Patients With Spinal Cord Injury (rTMS:Repetetive Transcranial Magnetic Stimulation)
NCT04372134
Primed vs. Unprimed rTMS in Chronic Stroke
NCT01757821
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Our research question is: In patients with upper extremity spasticity as a consequence of chronic stroke, does stimulation of the contralesional motor cortex with low-frequency (inhibitory) rTMS lead to reduction of spasticity and thereby clinical improvement in upper extremity function? Our rationale is that the pathophysiology of post-stroke spasticity is primarily driven by ensuant cortical derangement, and further, that this derangement can be mitigated to a clinically meaningful extent by proper utilization of rTMS directed at these foci. Optimized rTMS treatment protocols may even achieve efficacy that surpasses current mainstays of spasticity management.
Patients will be randomly assigned to receive either rTMS or placebo during their first treatment arm and then cross-over to receive the opposite treatment at the second treatment arm. A washout period of one month will occur between treatment arms. Each treatment arm will consist of 3 daily treatment sessions. Participants will present on a Monday for the pre-test assessment, Tuesday-Thursday for the treatment sessions and Friday for the post-test assessment. One treatment session will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere. Sham rTMS intensity will be 0% but with a similar sound and scalp sensation. Assessments will be made at each session, and will be conducted at pre-test, post-test, and one-month follow-up. The one month follow-up test will serve as the pretest for the next treatment arm. That is, after follow-up, patients will cross-over to receive the opposite treatment in the same format. Safety has already been demonstrated for our protocol. Data will be analyzed with methods appropriate to a single-subject crossover design (visual analysis, confidence intervals and 2-Standard Deviation bandwidth).
The primary outcome that we will measure is reduction of spasticity at the fingers and wrist. A secondary outcome of interest is functional improvement of the spastic upper limb.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
rTMS then Sham rTMS
repetitive Transcranial Magnetic Stimulation (rTMS)
repetitive Transcranial Magnetic Stimulation (rTMS)
The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.
Sham rTMS then Real rTMS
Sham repetitive Transcranial Magnetic Stimulation (Sham rTMS)
Sham repetitive Transcranial Magnetic Stimulation
Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
repetitive Transcranial Magnetic Stimulation (rTMS)
The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.
Sham repetitive Transcranial Magnetic Stimulation
Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. stroke at least six months prior to onset of study with chronic sequela of spasticity
3. stroke location- either cortical or subcortical
4. stroke type- either hemorrhagic or ischemic
5. stroke hemisphere- either left or right, dominant or non- dominant hemisphere
6. 18 years of age or older
7. gender- either male or female
8. ability to follow three-step directions
9. demonstration of 10 degrees of active extension at the metacarpophalangeal joint and wrist of the paretic upper extremity
10. demonstration of consistent resting motor evoked potential from ipsilesional and contralesional hemispheres
11. sufficient ambulation or wheelchair mobility to allow subject to present to treatment and testing areas with minimum assist
Exclusion Criteria
2. inability to follow three-step directions
3. anosognosia
4. moderate to severe receptive aphasia
5. inability to give informed consent
6. premorbid spasticity or neurologic impairment prior to stroke
7. co-morbidities impairing upper extremity function such as fracture or deformity
8. indwelling metal or medical devices incompatible with TMS
9. pregnancy
10. bi-hemispheric or multifocal stroke
11. dementia
12. neurolytic injection within the 3 months prior to onset of study or planned neurolytic injection during study period
13. planned vacation or travel during study period
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Minnesota
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matthew J Timp, DO
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota, Physical Medicine and Rehabilitation
James R Carey, PhD, PT
Role: STUDY_CHAIR
University of Minnesota, Program in Physical Therapy
Florence S John, MD, MPH
Role: STUDY_DIRECTOR
University of Minnesota, Physical Medicine and Rehabilitation
Kate Frost, MS
Role: STUDY_DIRECTOR
University of Minnesota, Program in Physical Therapy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Minnesota, Clinical and Translational Science Institute
Minneapolis, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Carmichael ST, Tatsukawa K, Katsman D, Tsuyuguchi N, Kornblum HI. Evolution of diaschisis in a focal stroke model. Stroke. 2004 Mar;35(3):758-63. doi: 10.1161/01.STR.0000117235.11156.55. Epub 2004 Feb 12.
Duque J, Murase N, Celnik P, Hummel F, Harris-Love M, Mazzocchio R, Olivier E, Cohen LG. Intermanual Differences in movement-related interhemispheric inhibition. J Cogn Neurosci. 2007 Feb;19(2):204-13. doi: 10.1162/jocn.2007.19.2.204.
Murase N, Duque J, Mazzocchio R, Cohen LG. Influence of interhemispheric interactions on motor function in chronic stroke. Ann Neurol. 2004 Mar;55(3):400-9. doi: 10.1002/ana.10848.
Kirton A, Chen R, Friefeld S, Gunraj C, Pontigon AM, Deveber G. Contralesional repetitive transcranial magnetic stimulation for chronic hemiparesis in subcortical paediatric stroke: a randomised trial. Lancet Neurol. 2008 Jun;7(6):507-13. doi: 10.1016/S1474-4422(08)70096-6. Epub 2008 May 1.
Grefkes C, Nowak DA, Wang LE, Dafotakis M, Eickhoff SB, Fink GR. Modulating cortical connectivity in stroke patients by rTMS assessed with fMRI and dynamic causal modeling. Neuroimage. 2010 Mar;50(1):233-42. doi: 10.1016/j.neuroimage.2009.12.029. Epub 2009 Dec 18.
Burn J, Dennis M, Bamford J, Sandercock P, Wade D, Warlow C. Epileptic seizures after a first stroke: the Oxfordshire Community Stroke Project. BMJ. 1997 Dec 13;315(7122):1582-7. doi: 10.1136/bmj.315.7122.1582.
Carey JR, Kimberley TJ, Lewis SM, Auerbach EJ, Dorsey L, Rundquist P, Ugurbil K. Analysis of fMRI and finger tracking training in subjects with chronic stroke. Brain. 2002 Apr;125(Pt 4):773-88. doi: 10.1093/brain/awf091.
Carey JR, Evans CD, Anderson DC, Bhatt E, Nagpal A, Kimberley TJ, Pascual-Leone A. Safety of 6-Hz primed low-frequency rTMS in stroke. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):185-92. doi: 10.1177/1545968307305458. Epub 2007 Sep 17.
Kakuda W, Abo M, Momosaki R, Yokoi A, Fukuda A, Ito H, Tominaga A, Umemori T, Kameda Y. Combined therapeutic application of botulinum toxin type A, low-frequency rTMS, and intensive occupational therapy for post-stroke spastic upper limb hemiparesis. Eur J Phys Rehabil Med. 2012 Mar;48(1):47-55. Epub 2011 Nov 9.
Kakuda W, Abo M, Kobayashi K, Momosaki R, Yokoi A, Fukuda A, Ito H, Tominaga A, Umemori T, Kameda Y. Anti-spastic effect of low-frequency rTMS applied with occupational therapy in post-stroke patients with upper limb hemiparesis. Brain Inj. 2011;25(5):496-502. doi: 10.3109/02699052.2011.559610.
Kakuda W, Abo M, Kobayashi K, Momosaki R, Yokoi A, Fukuda A, Ishikawa A, Ito H, Tominaga A. Low-frequency repetitive transcranial magnetic stimulation and intensive occupational therapy for poststroke patients with upper limb hemiparesis: preliminary study of a 15-day protocol. Int J Rehabil Res. 2010 Dec;33(4):339-45. doi: 10.1097/MRR.0b013e32833cdf10.
Kirton A, Deveber G, Gunraj C, Chen R. Cortical excitability and interhemispheric inhibition after subcortical pediatric stroke: plastic organization and effects of rTMS. Clin Neurophysiol. 2010 Nov;121(11):1922-9. doi: 10.1016/j.clinph.2010.04.021.
Kujirai T, Caramia MD, Rothwell JC, Day BL, Thompson PD, Ferbert A, Wroe S, Asselman P, Marsden CD. Corticocortical inhibition in human motor cortex. J Physiol. 1993 Nov;471:501-19. doi: 10.1113/jphysiol.1993.sp019912.
Liepert J, Storch P, Fritsch A, Weiller C. Motor cortex disinhibition in acute stroke. Clin Neurophysiol. 2000 Apr;111(4):671-6. doi: 10.1016/s1388-2457(99)00312-0.
Mally J, Dinya E. Recovery of motor disability and spasticity in post-stroke after repetitive transcranial magnetic stimulation (rTMS). Brain Res Bull. 2008 Jul 1;76(4):388-95. doi: 10.1016/j.brainresbull.2007.11.019. Epub 2007 Dec 26.
Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
Mathiowetz V, Federman S, Wiemer, D. Box and Block Test of Manual Dexterity: Norms for 6-19 Year Olds. CJOT. 1985b; 52(5): 241-245.
McDonnell MN, Orekhov Y, Ziemann U. The role of GABA(B) receptors in intracortical inhibition in the human motor cortex. Exp Brain Res. 2006 Aug;173(1):86-93. doi: 10.1007/s00221-006-0365-2. Epub 2006 Feb 18.
Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.
Sommerfeld DK, Gripenstedt U, Welmer AK. Spasticity after stroke: an overview of prevalence, test instruments, and treatments. Am J Phys Med Rehabil. 2012 Sep;91(9):814-20. doi: 10.1097/PHM.0b013e31825f13a3.
Theilig S, Podubecka J, Bosl K, Wiederer R, Nowak DA. Functional neuromuscular stimulation to improve severe hand dysfunction after stroke: does inhibitory rTMS enhance therapeutic efficiency? Exp Neurol. 2011 Jul;230(1):149-55. doi: 10.1016/j.expneurol.2011.04.010. Epub 2011 Apr 16.
Wassermann EM, Wedegaertner FR, Ziemann U, George MS, Chen R. Crossed reduction of human motor cortex excitability by 1-Hz transcranial magnetic stimulation. Neurosci Lett. 1998 Jul 10;250(3):141-4. doi: 10.1016/s0304-3940(98)00437-6.
Weiduschat N, Thiel A, Rubi-Fessen I, Hartmann A, Kessler J, Merl P, Kracht L, Rommel T, Heiss WD. Effects of repetitive transcranial magnetic stimulation in aphasic stroke: a randomized controlled pilot study. Stroke. 2011 Feb;42(2):409-15. doi: 10.1161/STROKEAHA.110.597864. Epub 2010 Dec 16.
Braddom, Randall L., Ralph M. Buschbacher. Ch 30 Spasticity Management. Physical Medicine & Rehabilitation. Saunders Elsevier 2007; 641-55.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1408M53261
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.