Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Methodist Hospital Research Institute | OTHER |
| Seraya Medical | INDUSTRY |
Not provided
Not provided
Transcranial magnetic stimulation for post-stroke upper-body motor deficits.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| repetitive Transcranial Magnetic Stimulation -On | Active Comparator | Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. |
|
| repetitive Transcranial Magnetic Stimulation -Off | Sham Comparator | Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive Transcranial Magnetic Stimulation -On | Device | Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| ARAT (Action Research Arm Test) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Chiu, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23090951 | Background | 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. | |
| 25206743 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
38 patients were screened 7 were screen fails. 2 withdrawn. 14 treated-Active, 15 treated-placebo.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Repetitive Transcranial Magnetic Stimulation -On | 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 |
| FG001 | Repetitive Transcranial Magnetic Stimulation -Off | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Repetitive Transcranial Magnetic Stimulation -On | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Brain Activation | Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI | Posted | Median | Inter-Quartile Range | voxels | One business day before treatment begins, one business day after treatment ends, up to 5 weeks |
|
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.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Repetitive Transcranial Magnetic Stimulation -On | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Ischemic Stroke | Nervous system disorders | Systematic Assessment | Relationship= Unlikely |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Chiu, M.D. | Houston Methodist Neurological Institute | 713-441-5801 | dmccane@houstonmethodist.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2018 | Jan 31, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2018 | Sep 9, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
Not provided
Not provided
Active repetitive transcranial magnetic stimulation administered through cap worn by patient under healthcare provider.
Not provided
Not provided
Double-blind, only the care provider is aware of active treatment assignment.
|
| repetitive Transcranial Magnetic Stimulation -Off | Device | 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. |
|
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 23506092 | Background | 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. |
| 19798637 | Background | 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. |
| 20809058 | Background | 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. |
| 16675743 | Background | 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. doi: 10.1161/01.STR.0000221233.55497.51. Epub 2006 May 4. |
| 19678808 | Background | 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. |
| 16890483 | Background | 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. doi: 10.1016/j.clinph.2006.06.712. Epub 2006 Aug 4. |
| 16809569 | Background | 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. doi: 10.1161/01.STR.0000231390.58967.6b. Epub 2006 Jun 29. |
| 18502315 | Background | 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. |
| 17079967 | Background | 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. doi: 10.1097/01.phm.0000242635.88129.38. |
| 20005962 | Background | 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. |
| Background | 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. |
| 10408769 | Background | Ashburner 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. |
| 11771995 | Background | 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. doi: 10.1006/nimg.2001.0978. |
| 20202481 | Background | 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. |
| 24893321 | Background | 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. |
| 16099512 | Background | 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. doi: 10.1016/j.jneumeth.2005.06.011. Epub 2005 Aug 15. |
| 8416078 | Background | Blair 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. |
| 2568739 | Background | 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. doi: 10.1007/BF02222236. |
| 21693536 | Background | 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. No abstract available. |
| Background | S. A. Helekar and H. U. Voss, |
| BG001 |
| Repetitive Transcranial Magnetic Stimulation -Off |
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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns | Mean | Full Range | years |
|
| Sex: Female, Male | 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns | Count of Participants | Participants |
|
| Race (NIH/OMB) | pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns | Count of Participants | Participants |
|
| Region of Enrollment | 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns | Number | participants |
|
| Fugl-Meyer motor arm score | Scale range is 0-66 with higher score representing a better outcome. | 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns | Median | Inter-Quartile Range | score on a scale |
|
| National Institutes of Health Stroke Scale (NIHSS) | Total score is 0-42, with the lower score representing a better outcome | 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns | Median | Inter-Quartile Range | score on a scale |
|
| Action Research Arm Test (ARAT) | Total score is 0-57 with the higher score representing a better outcome | 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns | Median | Inter-Quartile Range | score on a scale |
|
| Hand Grip Strength | 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns | Median | Inter-Quartile Range | Pounds |
|
| Pinch Strength | 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns | Median | Inter-Quartile Range | Pounds |
|
| Gait velocity on Timed Up and Go Test | 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns | Median | Inter-Quartile Range | feet per second |
|
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.
|
|
| 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 | Posted | Median | Inter-Quartile Range | score on a scale | 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 | Stroke patients greater than 3 months from qualifying stroke date | Posted | Median | Inter-Quartile Range | score on a scale | 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 | Posted | Median | Inter-Quartile Range | pounds | 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. | Posted | Median | Inter-Quartile Range | pounds | 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. | Posted | Median | Inter-Quartile Range | feet per second | 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 | Posted | Median | Inter-Quartile Range | score on a scale | One business day before treatment begins, one business day after treatment ends up to 5 weeks |
|
|
|
| 0 |
| 16 |
| 2 |
| 16 |
| 1 |
| 16 |
| EG001 | Repetitive Transcranial Magnetic Stimulation -Off | 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. | 0 | 15 | 2 | 15 | 3 | 15 |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment | Relationship= Unlikely |
|
| Migraine | Nervous system disorders | Systematic Assessment | Relationship=Unlikely |
|
| Renal stone | Renal and urinary disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment | 3 weeks post-treatment. Relationship=Unlikely |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Muscle cramps | General disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Transient tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|