Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke
An Innovative Approach to Restoration of Function in Chronic Ischemic Stroke Using a New Wearable Multifocal Brain Stimulator
1 other identifier
interventional
38
1 country
1
Brief Summary
Transcranial magnetic stimulation for post-stroke upper-body motor deficits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started May 2016
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2016
CompletedStudy Start
First participant enrolled
May 27, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2019
CompletedResults Posted
Study results publicly available
October 5, 2020
CompletedOctober 5, 2020
September 1, 2020
2.8 years
March 31, 2016
March 17, 2020
September 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Brain Activation
Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI
One business day before treatment begins, one business day after treatment ends, up to 5 weeks
Secondary Outcomes (6)
Fugl-Meyer Motor Arm Score
One business day before treatment begins, one business day after treatment ends up to 5 weeks
ARAT (Action Research Arm Test)
One business day before treatment begins, one business day after treatment ends up to 5 weeks
Hand Dynamometer
One business day before treatment begins, one business day after treatment ends up to 5 weeks
Pinch Dynamometer Score
One business day before treatment begins, one business day after treatment ends up to 5 weeks
TUG (Timed Up and Go Test)
One business day before treatment begins, one business day after treatment ends up to 5 weeks
- +1 more secondary outcomes
Study Arms (2)
repetitive Transcranial Magnetic Stimulation -On
ACTIVE COMPARATORParticipants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -Off
SHAM COMPARATORParticipants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
Interventions
Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
Eligibility Criteria
You may qualify if:
- Patients aged 18-80 years;
- Clinical diagnosis of chronic ischemic stroke recovering for more than 3 months with unilateral motor deficits of arm and leg, or arm alone; --
You may not qualify if:
- History of seizure;
- Epileptogenic activity (indicative of increased risk of seizures) on EEG;
- Any active unstable medical condition;
- Pregnancy;
- Schizophrenia, bipolar disorder, alcoholism, or substance abuse;
- Medications which in the investigator's clinical judgment significantly lower the seizure threshold;
- Presence of metal or electronic implants in the head (or any in the body that preclude MRI) , including pacemakers, defibrillators, aneurysm clips, neuro-stimulators, cochlear implants, metal in the eyes, etc.;
- Botulinum toxin use within two months prior to the screening visit or any planned use of botulinum toxin during the study
- Changes in NIHSS and motor assessment scores between Visit 1 and Visit 2 indicating that the patient's impairment is not stable. The following cutoffs, based on research establishing Clinically Important Differences, will be used for this determination:
- National Institutes of Health Stroke Scale: A change in total score of more than 2 points in either direction, or a change in the motor extremity score of more than 1 point in either direction.
- Fugl-Meyer Assessment of Sensorimotor Impairment: A change of more than 5 points in either direction on the upper-extremity motor score for the affected arm.
- Action Research Arm Test: A change of more than 5 points in either direction on the ARAT score for the affected arm.
- Any condition that precludes a high quality brain MRI scan.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David Chiu, MDlead
- The Methodist Hospital Research Institutecollaborator
- Seraya Medicalcollaborator
Study Sites (1)
Houston Methodist Hospital
Houston, Texas, 77030, United States
Related Publications (22)
Rehme AK, Grefkes C. Cerebral network disorders after stroke: evidence from imaging-based connectivity analyses of active and resting brain states in humans. J Physiol. 2013 Jan 1;591(1):17-31. doi: 10.1113/jphysiol.2012.243469. Epub 2012 Oct 22.
PMID: 23090951BACKGROUNDLi W, Li Y, Zhu W, Chen X. Changes in brain functional network connectivity after stroke. Neural Regen Res. 2014 Jan 1;9(1):51-60. doi: 10.4103/1673-5374.125330.
PMID: 25206743BACKGROUNDVarsou O, Macleod MJ, Schwarzbauer C. Functional connectivity magnetic resonance imaging in stroke: an evidence-based clinical review. Int J Stroke. 2014 Feb;9(2):191-8. doi: 10.1111/ijs.12033. Epub 2013 Mar 19.
PMID: 23506092BACKGROUNDAmeli M, Grefkes C, Kemper F, Riegg FP, Rehme AK, Karbe H, Fink GR, Nowak DA. Differential effects of high-frequency repetitive transcranial magnetic stimulation over ipsilesional primary motor cortex in cortical and subcortical middle cerebral artery stroke. Ann Neurol. 2009 Sep;66(3):298-309. doi: 10.1002/ana.21725.
PMID: 19798637BACKGROUNDChang WH, Kim YH, Bang OY, Kim ST, Park YH, Lee PK. Long-term effects of rTMS on motor recovery in patients after subacute stroke. J Rehabil Med. 2010 Sep;42(8):758-64. doi: 10.2340/16501977-0590.
PMID: 20809058BACKGROUNDKim YH, You SH, Ko MH, Park JW, Lee KH, Jang SH, Yoo WK, Hallett M. Repetitive transcranial magnetic stimulation-induced corticomotor excitability and associated motor skill acquisition in chronic stroke. Stroke. 2006 Jun;37(6):1471-6. doi: 10.1161/01.STR.0000221233.55497.51. Epub 2006 May 4.
PMID: 16675743BACKGROUNDKhedr EM, Etraby AE, Hemeda M, Nasef AM, Razek AA. Long-term effect of repetitive transcranial magnetic stimulation on motor function recovery after acute ischemic stroke. Acta Neurol Scand. 2010 Jan;121(1):30-7. doi: 10.1111/j.1600-0404.2009.01195.x. Epub 2009 Aug 11.
PMID: 19678808BACKGROUNDFitzgerald PB, Fountain S, Daskalakis ZJ. A comprehensive review of the effects of rTMS on motor cortical excitability and inhibition. Clin Neurophysiol. 2006 Dec;117(12):2584-96. doi: 10.1016/j.clinph.2006.06.712. Epub 2006 Aug 4.
PMID: 16890483BACKGROUNDFregni F, Boggio PS, Valle AC, Rocha RR, Duarte J, Ferreira MJ, Wagner T, Fecteau S, Rigonatti SP, Riberto M, Freedman SD, Pascual-Leone A. A sham-controlled trial of a 5-day course of repetitive transcranial magnetic stimulation of the unaffected hemisphere in stroke patients. Stroke. 2006 Aug;37(8):2115-22. doi: 10.1161/01.STR.0000231390.58967.6b. Epub 2006 Jun 29.
PMID: 16809569BACKGROUNDMally 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.
PMID: 18502315BACKGROUNDBoggio PS, Alonso-Alonso M, Mansur CG, Rigonatti SP, Schlaug G, Pascual-Leone A, Fregni F. Hand function improvement with low-frequency repetitive transcranial magnetic stimulation of the unaffected hemisphere in a severe case of stroke. Am J Phys Med Rehabil. 2006 Nov;85(11):927-30. doi: 10.1097/01.phm.0000242635.88129.38.
PMID: 17079967BACKGROUNDGrefkes 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.
PMID: 20005962BACKGROUNDHelekar, S.A., et al., Electromyographic motor-evoked potentials elicited by transcranial magnetic stimulation with rapidly moving permanent magnets mounted on a multisite stimulator cap, in 2013 Neuroscience Meeting Planner. 2013, Society for Neuroscience: San Diego, CA.
BACKGROUNDAshburner J, Friston KJ. Nonlinear spatial normalization using basis functions. Hum Brain Mapp. 1999;7(4):254-66. doi: 10.1002/(SICI)1097-0193(1999)7:4<254::AID-HBM4>3.0.CO;2-G.
PMID: 10408769BACKGROUNDTzourio-Mazoyer N, Landeau B, Papathanassiou D, Crivello F, Etard O, Delcroix N, Mazoyer B, Joliot M. Automated anatomical labeling of activations in SPM using a macroscopic anatomical parcellation of the MNI MRI single-subject brain. Neuroimage. 2002 Jan;15(1):273-89. doi: 10.1006/nimg.2001.0978.
PMID: 11771995BACKGROUNDBressler SL, Seth AK. Wiener-Granger causality: a well established methodology. Neuroimage. 2011 Sep 15;58(2):323-9. doi: 10.1016/j.neuroimage.2010.02.059. Epub 2010 Mar 2.
PMID: 20202481BACKGROUNDMatias FS, Gollo LL, Carelli PV, Bressler SL, Copelli M, Mirasso CR. Modeling positive Granger causality and negative phase lag between cortical areas. Neuroimage. 2014 Oct 1;99:411-8. doi: 10.1016/j.neuroimage.2014.05.063. Epub 2014 Jun 2.
PMID: 24893321BACKGROUNDChen Y, Bressler SL, Ding M. Frequency decomposition of conditional Granger causality and application to multivariate neural field potential data. J Neurosci Methods. 2006 Jan 30;150(2):228-37. doi: 10.1016/j.jneumeth.2005.06.011. Epub 2005 Aug 15.
PMID: 16099512BACKGROUNDBlair RC, Karniski W. An alternative method for significance testing of waveform difference potentials. Psychophysiology. 1993 Sep;30(5):518-24. doi: 10.1111/j.1469-8986.1993.tb02075.x.
PMID: 8416078BACKGROUNDChiavarini M, Morini G, Barocelli E, Bordi F, Plazzi PV, Vitali T, Impicciatore M. Influence of urea-equivalent groups in position 5 of 2-amino, 2-(1-aminoethylidenamino) and 2-guanidino thiazole derivatives on H2-receptor antagonist activity in gastric fistula cat. Agents Actions. 1989 Apr;27(1-2):192-4. doi: 10.1007/BF02222236.
PMID: 2568739BACKGROUNDCarlowe J. Investigation into home care of elderly people shows cases of "serious neglect". BMJ. 2011 Jun 21;342:d3904. doi: 10.1136/bmj.d3904. No abstract available.
PMID: 21693536BACKGROUNDS. A. Helekar and H. U. Voss,
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Chiu, M.D.
- Organization
- Houston Methodist Neurological Institute
Study Officials
- PRINCIPAL INVESTIGATOR
David Chiu, MD
The Methodist Hospital Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind, only the care provider is aware of active treatment assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator/Sponsor-Investigator
Study Record Dates
First Submitted
March 31, 2016
First Posted
June 29, 2016
Study Start
May 27, 2016
Primary Completion
March 13, 2019
Study Completion
March 13, 2019
Last Updated
October 5, 2020
Results First Posted
October 5, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share