Repetitive Transcranial Magnetic Stimulation in Post Stroke Upper Limb Spasticity
Effect of Repetitive Transcranial Magnetic Stimulation Over Contralesional Dorsal Premotor Cortex on Post Stroke Upper Limb Spasticity
1 other identifier
interventional
37
1 country
1
Brief Summary
The reticulospinal pathway (RSP) is at the center of spasticity mechanism. The RSP indirectly synapses with motor neurons via interneurons in the ventromedial intermediate zone in both halves of the spinal cord, and directly synapses with motor neurons of proximal extremity muscles. The main motor cortex region controlling unilateral RSP is the premotor cortex. That is, a single limb is represented in both premotor cortices. This suggests theoretically that if the corticoreticular pathway controlling RSP is modulated by dorsal premotor cortex stimulation, there may be a change in the regulation of the intraspinal network regulating the stretch reflex. Therefore, the hypothesis in this study is that the application of repetitive transcranial magnetic stimulation (rTMS) over the contralesional dorsal premotor cortex in chronic stroke patients changes the severity of spasticity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2019
CompletedFirst Posted
Study publicly available on registry
August 21, 2019
CompletedStudy Start
First participant enrolled
September 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2021
CompletedApril 1, 2022
March 1, 2022
1.8 years
August 16, 2019
March 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Ashworth Scale
The modified Ashworth Scale is a scale that clinically evaluates the presence and severity of muscle tone increase. It is an ordinal scale that evaluates spasticity at six levels between 0 and 4 (0, 1, 1+, 2, 3, 4). The severity of spasticity increases as the score increases. Score 0 indicates no increase in muscle tone, while score 4 indicates that the affected part is rigid. Six levels between 0 and 5 (0, 1, 2, 3, 4, 5) will be used in statistical analysis. The score of 1+ will be treated as 2, 2 as 3, 3 as 4 and 4 as 5.
Pre-intervention (baseline) and immediately after intervention (post-intervention), up to 45 minutes
Secondary Outcomes (1)
F wave parameters
Pre-intervention (baseline) and immediately after intervention (post-intervention), up to 45 minutes
Study Arms (3)
Excitatory repetitive transcranial magnetic stimulation group
EXPERIMENTALOne session of repetitive transcranial magnetic stimulation (rTMS) treatment with 10 Hz frequency will be applied to the contralesional dorsal premotor cortex. Application will be performed with Neurosoft-Neuro MS / D device. 90% of the motor threshold will be used in the stimulation. Stimulation is planned for a total of 15 minutes and a total of 1500 beats in the form of a 5 seconds 10 Hz stimulation followed by a 25 seconds interval.
Inhibitory repetitive transcranial magnetic stimulation group
EXPERIMENTALOne session of repetitive transcranial magnetic stimulation (rTMS) treatment at 1 Hz frequency will be applied to the contralesional dorsal premotor cortex. Application will be performed with Neurosoft-Neuro MS / D device. 90% of the motor threshold will be used in the stimulation. Stimulation is planned for a total of 25 minutes and a total of 1500 beats in the form of 1 Hz stimulation.
Sham repetitive transcranial magnetic stimulation group
SHAM COMPARATORSingle session of sham application for a total of 25 minutes. Sham application will be performed by holding the probe of the device vertically to the vertex. The device will be operated at the lowest operating power of 1 to produce the same stimulation sounds like the active application. The device operating at this power is not likely to give any stimulation due to the probe being held upright.
Interventions
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive intervention that uses magnetic fields to stimulate nerve cells to improve the symptoms of a variety of disorders, including stroke-related motor impairment.
Eligibility Criteria
You may qualify if:
- ≥ 18 years
- Stroke history ≥ 1 year
- Having a first stroke
- Grade 2 or 3 muscle tone according to the Modified Ashworth Scale (MAS) assessment in at least one of the elbow, wrist and finger flexors
- Signed consent to participate in the study
You may not qualify if:
- To have a clinical condition (metallic implant, cardiac pace, pregnancy, breastfeeding, claustrophobia, epilepsy, head trauma, cranial operation history) that will constitute a contraindication to transcranial magnetic stimulation
- Presence of malignancy
- Pregnancy or breastfeeding
- Non-stroke disease or lesion affecting the sensorimotor system
- Presence of pump/shunt
- Advanced cognitive impairment
- To have been rehabilitated in the last 3 months
- Botulinum toxin injection in the last 3 months
- Taking systemic antispastic drugs (Patients taking these drugs may be included in the study after a period of at least 3 times the half-life of the drug used if they agree to quit)
- Previously treated with TMS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
İlker Şengül
Izmir, 35360, Turkey (Türkiye)
Related Publications (9)
Li S, Francisco GE. New insights into the pathophysiology of post-stroke spasticity. Front Hum Neurosci. 2015 Apr 10;9:192. doi: 10.3389/fnhum.2015.00192. eCollection 2015.
PMID: 25914638BACKGROUNDBurke D, Wissel J, Donnan GA. Pathophysiology of spasticity in stroke. Neurology. 2013 Jan 15;80(3 Suppl 2):S20-6. doi: 10.1212/WNL.0b013e31827624a7.
PMID: 23319482BACKGROUNDLemon RN. Descending pathways in motor control. Annu Rev Neurosci. 2008;31:195-218. doi: 10.1146/annurev.neuro.31.060407.125547.
PMID: 18558853BACKGROUNDBaumer T, Bock F, Koch G, Lange R, Rothwell JC, Siebner HR, Munchau A. Magnetic stimulation of human premotor or motor cortex produces interhemispheric facilitation through distinct pathways. J Physiol. 2006 May 1;572(Pt 3):857-68. doi: 10.1113/jphysiol.2006.104901.
PMID: 16497712BACKGROUNDRossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
PMID: 19833552BACKGROUNDWassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16. doi: 10.1016/s0168-5597(97)00096-8.
PMID: 9474057BACKGROUNDBohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
PMID: 3809245BACKGROUNDWupuer S, Yamamoto T, Katayama Y, Motohiko H, Sekiguchi S, Matsumura Y, Kobayashi K, Obuchi T, Fukaya C. F-wave suppression induced by suprathreshold high-frequency repetitive trascranial magnetic stimulation in poststroke patients with increased spasticity. Neuromodulation. 2013 May-Jun;16(3):206-11; discussion 211. doi: 10.1111/j.1525-1403.2012.00520.x. Epub 2012 Oct 24.
PMID: 23094969BACKGROUNDSengul I, Askin A, Altun A, Tosun A. Anti-spastic effect of contralesional dorsal premotor cortex stimulation in stroke patients with moderate-to-severe spastic paresis: a randomized, controlled pilot trial. Acta Neurol Belg. 2023 Aug;123(4):1345-1354. doi: 10.1007/s13760-023-02212-2. Epub 2023 Feb 21.
PMID: 36809647DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
İlker Şengül, M.D.
İzmir Katip Çelebi University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 16, 2019
First Posted
August 21, 2019
Study Start
September 9, 2019
Primary Completion
June 27, 2021
Study Completion
June 27, 2021
Last Updated
April 1, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share