Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke

Stroke Clinical Trial

Official title:

An Innovative Approach to Restoration of Function in Chronic Ischemic Stroke Using a New Wearable Multifocal Brain Stimulator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817087
• Other study ID #: Pro00014213
• Status: Completed
• Phase: N/A
• Start date: May 27, 2016
• Est. completion date: March 13, 2019

Study information

• Verified date: September 2020
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transcranial magnetic stimulation for post-stroke upper-body motor deficits.

Description:

This study uses transcranial magnetic stimulation (magnetic pulses delivered through a specially designed cap worn on the head aimed at specific motor areas of the brain (brain areas responsible for the body's physical movements) to test whether upper-body motor function can be improved.

This is a double-blind study where half of participants will receive active transcranial stimulation and the other half of the participants will receive no transcranial magnetic stimulation; all participants will wear the cap. Participants and some members of the research team will not know who received active magnetic brain stimulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 13, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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; --

Exclusion Criteria:

• 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.;

• Any changes in medications prescribed for the treatment of stroke impairment within six weeks prior to inclusion in the study or at any time during the study.

• 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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• repetitive Transcranial Magnetic Stimulation -On
Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
• repetitive Transcranial Magnetic Stimulation -Off
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.

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
David Chiu, MD	Seraya Medical Systems, LLC, The Methodist Hospital System

Country where clinical trial is conducted

United States, 

References & Publications (22)

Ameli 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. — View Citation

Ashburner J, Friston KJ. Nonlinear spatial normalization using basis functions. Hum Brain Mapp. 1999;7(4):254-66. — View Citation

Blair RC, Karniski W. An alternative method for significance testing of waveform difference potentials. Psychophysiology. 1993 Sep;30(5):518-24. — View Citation

Boggio 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. — View Citation

Bressler 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. — View Citation

Carlowe J. Investigation into home care of elderly people shows cases of "serious neglect". BMJ. 2011 Jun 21;342:d3904. doi: 10.1136/bmj.d3904. — View Citation

Chang 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. — View Citation

Chen 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. Epub 2005 Aug 15. — View Citation

Chiavarini 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. — View Citation

Fitzgerald 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. Epub 2006 Aug 4. Review. — View Citation

Fregni 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. Epub 2006 Jun 29. — View Citation

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. — View Citation

Helekar, 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.

Khedr 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. — View Citation

Kim 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. Epub 2006 May 4. Erratum in: Stroke. 2006 Nov;37(11):2861. — View Citation

Li 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. — View Citation

Málly 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. — View Citation

Matias 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. — View Citation

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. Review. — View Citation

S. A. Helekar and H. U. Voss,

Tzourio-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. — View Citation

Varsou 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. Review. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fugl-Meyer Motor Arm Score	Change in arm motor function Total score range is 0-66 with the higher number representing a better outcome	One business day before treatment begins, one business day after treatment ends up to 5 weeks
Secondary	ARAT (Action Research Arm Test)	Change in arm and hand motor function Total score range is 0-57 with the higher number representing a better outcome	One business day before treatment begins, one business day after treatment ends up to 5 weeks
Secondary	Hand Dynamometer	Change in grip strength The higher the number represents better outcome	One business day before treatment begins, one business day after treatment ends up to 5 weeks
Secondary	Pinch Dynamometer Score	Change in pinch strength. The higher the number, the better the outcome.	One business day before treatment begins, one business day after treatment ends up to 5 weeks
Secondary	TUG (Timed Up and Go Test)	Change in gait velocity on Timed Up and Go Test. The lower the time recorded, the better the outcome.	One business day before treatment begins, one business day after treatment ends up to 5 weeks
Secondary	National Institutes of Health Stroke Scale (NIHSS)	Change in National Institutes of Health Stroke Scale (NIHSS) Total score range is 0-42 with the lower number representing a better outcome	One business day before treatment begins, one business day after treatment ends up to 5 weeks