Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke

• Sponsor: David Chiu, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT02817087
• Collaborator: The Methodist Hospital Research Institute (Other), Seraya Medical Systems, LLC (Other)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 33.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: repetitive Transcranial Magnetic Stimulation -On; Device: repetitive Transcranial Magnetic Stimulation -Off	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Active repetitive transcranial magnetic stimulation administered through cap worn by patient under healthcare provider.Active repetitive transcranial magnetic stimulation administered through cap worn by patient under healthcare provider.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Double-blind, only the care provider is aware of active treatment assignment.
• Primary Purpose: Treatment
• Official Title: An Innovative Approach to Restoration of Function in Chronic Ischemic Stroke Using a New Wearable Multifocal Brain Stimulator
• Actual Study Start Date: May 27, 2016
• Actual Primary Completion Date: Mar 13, 2019
• Actual Study Completion Date: Mar 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: repetitive Transcranial Magnetic Stimulation -On Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.	Device: repetitive Transcranial Magnetic Stimulation -On; Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain; Other Names: transcranial magnetic stimulation (TMS) Transcranial Rotating Permanent Magnet Stimulation (TRPMS) repetitive Transcranial Magnetic Stimulation (rTMS)
Sham Comparator: repetitive Transcranial Magnetic Stimulation -Off Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.	Device: 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.; Other Names: sham treatment Control Group

Outcome Measures

Primary Outcome Measures

1. Changes in Brain Activation [One business day before treatment begins, one business day after treatment ends, up to 5 weeks]

   Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI

Secondary Outcome Measures

1. Fugl-Meyer Motor Arm Score [One business day before treatment begins, one business day after treatment ends up to 5 weeks]

   Change in arm motor function Total score range is 0-66 with the higher number representing a better outcome

2. ARAT (Action Research Arm Test) [One business day before treatment begins, one business day after treatment ends up to 5 weeks]

   Change in arm and hand motor function Total score range is 0-57 with the higher number representing a better outcome

3. Hand Dynamometer [One business day before treatment begins, one business day after treatment ends up to 5 weeks]

   Change in grip strength The higher the number represents better outcome

4. Pinch Dynamometer Score [One business day before treatment begins, one business day after treatment ends up to 5 weeks]

   Change in pinch strength. The higher the number, the better the outcome.

5. TUG (Timed Up and Go Test) [One business day before treatment begins, one business day after treatment ends up to 5 weeks]

   Change in gait velocity on Timed Up and Go Test. The lower the time recorded, the better the outcome.

6. National Institutes of Health Stroke Scale (NIHSS) [One business day before treatment begins, one business day after treatment ends up to 5 weeks]

   Change in National Institutes of Health Stroke Scale (NIHSS) Total score range is 0-42 with the lower number representing a better outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Houston Methodist Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• David Chiu, MD
• The Methodist Hospital Research Institute
• Seraya Medical Systems, LLC

Investigators

• Principal Investigator: David Chiu, MD, The Methodist Hospital Research Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 1, 2018
• Informed Consent Form - May 8, 2018

More Information

Publications

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

• Responsible Party: David Chiu, MD, Principal Investigator/Sponsor-Investigator, The Methodist Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT02817087
• Other Study ID Numbers: Pro00014213
• First Posted: Jun 29, 2016
• Last Update Posted: Oct 5, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by David Chiu, MD, Principal Investigator/Sponsor-Investigator, The Methodist Hospital Research Institute: Stroke; chronic ischemic stroke; cerebrovascular accident (CVA); ischaemic stroke
• Additional relevant MeSH terms: Stroke; Ischemic Stroke

Study Results

Participant Flow

Recruitment Details	38 patients were screened 7 were screen fails. 2 withdrawn. 14 treated-Active, 15 treated-placebo.

Arm/Group Title	Repetitive Transcranial Magnetic Stimulation -On	Repetitive Transcranial Magnetic Stimulation -Off
Arm/Group Description	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to 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.
Period Title: Overall Study
STARTED	16	15
COMPLETED	14	15
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Repetitive Transcranial Magnetic Stimulation -On	Repetitive Transcranial Magnetic Stimulation -Off	Total
Arm/Group Description	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to 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.	Total of all reporting groups
Overall Participants	16	15	31
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	6 37.5%	7 46.7%	13 41.9%
>=65 years	8 50%	8 53.3%	16 51.6%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	65.4	66.3	65.8
Sex: Female, Male (Count of Participants)
Female	6 37.5%	9 60%	15 48.4%
Male	8 50%	6 40%	14 45.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 12.5%	1 6.7%	3 9.7%
Not Hispanic or Latino	12 75%	14 93.3%	26 83.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 6.3%	0 0%	1 3.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 18.8%	0 0%	3 9.7%
White	10 62.5%	15 100%	25 80.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	14 87.5%	15 100%	29 93.5%
Fugl-Meyer motor arm score (score on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [score on a scale]	43	25	37.0
National Institutes of Health Stroke Scale (NIHSS) (score on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [score on a scale]	3	3	3.0
Action Research Arm Test (ARAT) (score on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [score on a scale]	29	6	14.0
Hand Grip Strength (Pounds) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Pounds]	19.7	30.6	21.8
Pinch Strength (Pounds) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Pounds]	6.5	3.83	4.7
Gait velocity on Timed Up and Go Test (feet per second) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [feet per second]	1.32	1.45	1.45

Outcome Measures

1. Primary Outcome

Title	Changes in Brain Activation
Description	Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI
Time Frame	One business day before treatment begins, one business day after treatment ends, up to 5 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Repetitive Transcranial Magnetic Stimulation -On	Repetitive Transcranial Magnetic Stimulation -Off
Arm/Group Description	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to 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.
Measure Participants	14	15
Median (Inter-Quartile Range) [voxels]	48.5	-30

2. Secondary Outcome

Title	Fugl-Meyer Motor Arm Score
Description	Change in arm motor function Total score range is 0-66 with the higher number representing a better outcome
Time Frame	One business day before treatment begins, one business day after treatment ends up to 5 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Repetitive Transcranial Magnetic Stimulation -On	Repetitive Transcranial Magnetic Stimulation -Off
Arm/Group Description	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to 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.
Measure Participants	14	15
Median (Inter-Quartile Range) [score on a scale]	2.5	2.0

3. Secondary Outcome

Title	ARAT (Action Research Arm Test)
Description	Change in arm and hand motor function Total score range is 0-57 with the higher number representing a better outcome
Time Frame	One business day before treatment begins, one business day after treatment ends up to 5 weeks

Outcome Measure Data

Analysis Population Description

Stroke patients greater than 3 months from qualifying stroke date

Arm/Group Title	Repetitive Transcranial Magnetic Stimulation -On	Repetitive Transcranial Magnetic Stimulation -Off
Arm/Group Description	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to 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.
Measure Participants	14	15
Median (Inter-Quartile Range) [score on a scale]	0	0

4. Secondary Outcome

Title	Hand Dynamometer
Description	Change in grip strength The higher the number represents better outcome
Time Frame	One business day before treatment begins, one business day after treatment ends up to 5 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Repetitive Transcranial Magnetic Stimulation -On	Repetitive Transcranial Magnetic Stimulation -Off
Arm/Group Description	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to 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.
Measure Participants	14	15
Median (Inter-Quartile Range) [pounds]	1.8	0

5. Secondary Outcome

Title	Pinch Dynamometer Score
Description	Change in pinch strength. The higher the number, the better the outcome.
Time Frame	One business day before treatment begins, one business day after treatment ends up to 5 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Repetitive Transcranial Magnetic Stimulation -On	Repetitive Transcranial Magnetic Stimulation -Off
Arm/Group Description	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to 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.
Measure Participants	14	15
Median (Inter-Quartile Range) [pounds]	.17	.33

6. Secondary Outcome

Title	TUG (Timed Up and Go Test)
Description	Change in gait velocity on Timed Up and Go Test. The lower the time recorded, the better the outcome.
Time Frame	One business day before treatment begins, one business day after treatment ends up to 5 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Repetitive Transcranial Magnetic Stimulation -On	Repetitive Transcranial Magnetic Stimulation -Off
Arm/Group Description	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to 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.
Measure Participants	14	15
Median (Inter-Quartile Range) [feet per second]	.04	0

7. Secondary Outcome

Title	National Institutes of Health Stroke Scale (NIHSS)
Description	Change in National Institutes of Health Stroke Scale (NIHSS) Total score range is 0-42 with the lower number representing a better outcome
Time Frame	One business day before treatment begins, one business day after treatment ends up to 5 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Repetitive Transcranial Magnetic Stimulation -On	Repetitive Transcranial Magnetic Stimulation -Off
Arm/Group Description	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to 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.
Measure Participants	14	15
Median (Inter-Quartile Range) [score on a scale]	0	0

Adverse Events

Time Frame	Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
Adverse Event Reporting Description	All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
Arm/Group Title	Repetitive Transcranial Magnetic Stimulation -On		Repetitive Transcranial Magnetic Stimulation -Off
Arm/Group Description	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain		Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to 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.
All Cause Mortality
	Repetitive Transcranial Magnetic Stimulation -On		Repetitive Transcranial Magnetic Stimulation -Off
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/15 (0%)
Serious Adverse Events
	Repetitive Transcranial Magnetic Stimulation -On		Repetitive Transcranial Magnetic Stimulation -Off
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/16 (12.5%)		2/15 (13.3%)
Nervous system disorders
Acute Ischemic Stroke	1/16 (6.3%)	1	0/15 (0%)	0
Migraine	0/16 (0%)	0	1/15 (6.7%)	1
Seizure	1/16 (6.3%)	1	0/15 (0%)	0
Renal and urinary disorders
Urinary tract infection	1/16 (6.3%)	1	0/15 (0%)	0
Renal stone	0/16 (0%)	0	1/15 (6.7%)	1
Other (Not Including Serious) Adverse Events
	Repetitive Transcranial Magnetic Stimulation -On		Repetitive Transcranial Magnetic Stimulation -Off
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/16 (6.3%)		3/15 (20%)
Ear and labyrinth disorders
Transient tinnitus	1/16 (6.3%)	1	0/15 (0%)	0
General disorders
Fall	0/16 (0%)	0	1/15 (6.7%)	1
Fatigue	0/16 (0%)	0	1/15 (6.7%)	1
Muscle cramps	0/16 (0%)	0	1/15 (6.7%)	1
Dizziness	1/16 (6.3%)	1	1/15 (6.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.