Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT07202195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
At Home Use of Stimulation Suits for Managing MS Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D002524', 'term': 'Cerebellar Ataxia'}, {'id': 'D001259', 'term': 'Ataxia'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Multiple Sclerosis (MS) type', 'timeFrame': 'Will be collected (at baseline) when a partcipant is found eligible', 'description': 'MS type: primary progressive (PP), secundary progressive (SP), relapsing remitting (RR), ..'}, {'measure': 'age', 'timeFrame': 'Will be collected at baseline when a partcipant is found eligible', 'description': 'Age (years)'}, {'measure': 'sex', 'timeFrame': 'Will be collected at baseline when a partcipant is found eligible', 'description': 'sex (m/v)'}, {'measure': 'height', 'timeFrame': 'Will be collected at baseline when a partcipant is found eligible', 'description': 'height (cm)'}, {'measure': 'weight', 'timeFrame': 'Will be collected at baseline when a partcipant is found eligible', 'description': 'weight (kg),'}, {'measure': 'Expanded Disability Status Score (EDSS)', 'timeFrame': 'Will be collected (at baseline) when a partcipant is found eligible', 'description': 'latest EDSS: The Expanded Disability Status Scale measures your current level of disability.\n\nValues: (0.0 -10.0) A higher score indicates a worse outcome'}, {'measure': 'Time since diagnosis', 'timeFrame': 'Will be collected (at baseline) when a partcipant is found eligible', 'description': 'time since diagnosis (years)'}, {'measure': 'Medication', 'timeFrame': 'Will be collected (at baseline) when a partcipant is found eligible', 'description': 'Previous and current MS medication. previous and current ataxia or spasticity medication will be listed'}, {'measure': 'Onset Spasticity and/or ataxia', 'timeFrame': 'Will be collected (at baseline) when a partcipant is found eligible', 'description': 'Time since onset of ataxia or spasticity. (years)'}, {'measure': 'Comorbidities', 'timeFrame': 'Will be collected (at baseline) when a partcipant is found eligible', 'description': 'Comorbidities will be listed.'}], 'primaryOutcomes': [{'measure': 'NHPT+SSST score', 'timeFrame': 'After one and six weeks of stimulation for the intervention group. The control group will be assessed at the same time points.', 'description': 'The primary outcome will be a combined measure of upper and lower extremity motor function, consisting of the Nine Hole Peg Test and the Six Spot step test (labelled NHPT+SSST score). Values are expressed in seconds.\n\nA higher score, indicates a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Six spot step test (SSST)', 'timeFrame': 'SSST assessment will take place after weeks 1 and 6 of stimulation.', 'description': 'Similar to the T25FW, the SSST is a quantitative measure of lower extremity function. The test contains a rectangular field with six circles on the floor following a criss-cross course. Five circles contain a block. The starting-point is the first circle, which does not contain a block. From there the patient walks to the other side of the field and kicks the blocks out of the five circles, as quickly as possible. The task is immediately administered again by having the patient walk back the same route. Both the dominant and non-dominant legs are tested twice.\n\nThe Maximum value: 300.0 seconds A higher score indicates a worse outcome.'}, {'measure': 'Nine Hole Peg Test (NHPT)', 'timeFrame': 'NHPT assessment will take place after weeks 1 and 6 of stimulation.', 'description': 'The Nine-Hole Peg Test (NHPT) is an assessment tool used to evaluate movement speed, particularly fine hand motor skills. The patient must take nine pegs from a container as quickly as possible and place them into the holes on a board. Afterwards, the patient must remove the pegs and return them to the container. The time taken to complete the task is measured. The patient may only use the hand being tested and must repeat the procedure for each peg individually (they are not allowed to pick up multiple pegs at once).\n\nA higher score indicates a worse outcome.'}, {'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': 'MAS assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation.', 'description': 'The Modified Ashworth Scale (MAS) is designed to objectively assess the degree of spasticity. The MAS measures the level of hypertonia in the left and right elbows and knees. The therapist evaluates the muscle tone and records the highest level of tone felt during five repetitions per joint, using a six-point scale (0 = no increase in muscle tone, 4 = limb rigid in flexion or extension and cannot be moved).\n\nA higher score indicates a worse outcome.'}, {'measure': 'Scale for the Assessment and Rating of Ataxia (SARA)', 'timeFrame': 'SARA assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation.', 'description': 'SARA is a clinical scale which assesses a range of different impairments in cerebellar ataxia. The scale is made up of 8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.\n\nThe minimum value: 0 The maximum value: 40 A higher score indicates a worse outcome.'}, {'measure': 'Numeric Rating Scale (NRS)', 'timeFrame': 'NRS assessments will take place after weeks 1 and 6 of stimulation.', 'description': 'The severity of ataxia and spasticity will be documented bij a numeric scale. The minimum value: 0 The maximum value: 10 A higher score indicates a worse outcome.'}, {'measure': 'The patient-Determined Disease Steps (PDDS)', 'timeFrame': 'PDDS assessment will take place after weeks 1 and 6 of stimulation.', 'description': 'A questionnaire on how a person with MS preceives their capacity to walk. The patient needs to chose one descrition the reflects their condition the best.\n\nThe minimum value: 0 The maximum value: 8 A higher score, indicates a worse outcome.'}, {'measure': 'The 12-item Multiple Sclerosis Walking Scale (MSWS12)', 'timeFrame': 'MSWS-12 assessment will take place after weeks 1 and 6 of stimulation.', 'description': "The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a self-report measure of the impact of MS on the individual's walking ability.\n\nThe minimum value: 0 The maximum value: 100 A higher score, indicate a worse outcome."}, {'measure': 'The 36-item Manual Ability Measurement (MAM36)', 'timeFrame': 'MAM36 assessment will take place after weeks 1 and 6 of stimulation.', 'description': "The Manual Ability Measure (MAM) is designed as an outcome instrument to assess hand function based on the patient's responses to functional questions. Tasks are rated on a scale from 0 (cannot be done) to 4 (easy to do). Total scores range from 0 to 144.\n\nA higher score indicates greater perceived manual ability."}, {'measure': 'The EuroQol Questionnaire (EQ-D5)', 'timeFrame': 'EQ-5D assessment will take place after weeks 1 and 6 of stimulation.', 'description': "The EQ-5D is a standardized instrument that provides a score across five health dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. (5 items, three or five response categories) In addition, the patient must indicate how they perceive their overall health status on a scale from 0 to 100. To interpret the results correctly, it is important that the healthcare provider is familiar with the patient's demographic information. (8 items) A higher score indicates a worse outcome."}, {'measure': 'SymptoMScreen', 'timeFrame': 'SymptoMScreen assessment will take place after weeks 1 and 6 of stimulation.', 'description': "A tool for rapid assessment of MS symptom ( the six most common areas where symptomatic complaints occur and are discussed during clinical visits) severity in routine clinical practice. It uses a 7-point Likert scales for each functional domain (0 = not affected at all, 6 = total limitation/I'm unable to do most daily activities).\n\nThe minimum value: 0 The maximum value: 72 A higher score indicates a worse outcome."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ataxia', 'spasticity', 'multiple sclerosis', 'MS', 'neuromodulation suit', 'stimulation suit', 'exopluse molli suit', 'home-based rehabilitation', 'symptom management'], 'conditions': ['Multiple Sclerosis', 'MS (Multiple Sclerosis)', 'Spasticity With Multiple Sclerosis', 'Ataxia - Other', 'Ataxia, Cerebellar', 'Ataxia, Motor', 'Spasticity', 'Home Based Care']}, 'referencesModule': {'references': [{'pmid': '40129510', 'type': 'BACKGROUND', 'citation': 'Weller LJR, Sherwood SM, Ng SH, Vellaichamy M, Noordin AA, Tan LY, Mahadev A, Yeo TH, Ng ZM. Can External Neuromodulation Garments Improve Gait and Function in Children With Cerebral Palsy? A Prospective Single-Arm Study. Health Sci Rep. 2025 Mar 23;8(3):e70566. doi: 10.1002/hsr2.70566. eCollection 2025 Mar.'}, {'pmid': '38105806', 'type': 'BACKGROUND', 'citation': 'Skjerbaek AG, Dalgas U, Stenager E, Boesen F, Hvid LG. The six spot step test is superior in detecting walking capacity impairments compared to short- and long-distance walk tests in persons with multiple sclerosis. Mult Scler J Exp Transl Clin. 2023 Dec 12;9(4):20552173231218127. doi: 10.1177/20552173231218127. eCollection 2023 Oct-Dec.'}, {'pmid': '35820358', 'type': 'BACKGROUND', 'citation': 'Riemenschneider M, Trenel P, Norgaard M, Boesen F. Multimethodological validation of the modified fatigue impact scale in a Danish population of people with Multiple Sclerosis. Mult Scler Relat Disord. 2022 Sep;65:104012. doi: 10.1016/j.msard.2022.104012. Epub 2022 Jul 2.'}, {'pmid': '11491192', 'type': 'BACKGROUND', 'citation': 'Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.'}, {'pmid': '37370612', 'type': 'BACKGROUND', 'citation': 'Perpetuini D, Russo EF, Cardone D, Palmieri R, De Giacomo A, Pellegrino R, Merla A, Calabro RS, Filoni S. Use and Effectiveness of Electrosuit in Neurological Disorders: A Systematic Review with Clinical Implications. Bioengineering (Basel). 2023 Jun 2;10(6):680. doi: 10.3390/bioengineering10060680.'}, {'pmid': '32778118', 'type': 'BACKGROUND', 'citation': 'Palmcrantz S, Pennati GV, Bergling H, Borg J. Feasibility and potential effects of using the electro-dress Mollii on spasticity and functioning in chronic stroke. J Neuroeng Rehabil. 2020 Aug 10;17(1):109. doi: 10.1186/s12984-020-00740-z.'}, {'pmid': '22612360', 'type': 'BACKGROUND', 'citation': 'Moller AB, Bibby BM, Skjerbaek AG, Jensen E, Sorensen H, Stenager E, Dalgas U. Validity and variability of the 5-repetition sit-to-stand test in patients with multiple sclerosis. Disabil Rehabil. 2012;34(26):2251-8. doi: 10.3109/09638288.2012.683479. Epub 2012 May 22.'}, {'pmid': '17463075', 'type': 'BACKGROUND', 'citation': 'Miller L, Mattison P, Paul L, Wood L. The effects of transcutaneous electrical nerve stimulation (TENS) on spasticity in multiple sclerosis. Mult Scler. 2007 May;13(4):527-33. doi: 10.1177/1352458506071509. Epub 2007 Jan 29.'}, {'pmid': '26856941', 'type': 'BACKGROUND', 'citation': 'Milinis K, Tennant A, Young CA; TONiC study group. Spasticity in multiple sclerosis: Associations with impairments and overall quality of life. Mult Scler Relat Disord. 2016 Jan;5:34-9. doi: 10.1016/j.msard.2015.10.007. Epub 2015 Oct 22.'}, {'pmid': '33620411', 'type': 'BACKGROUND', 'citation': 'McGinley MP, Goldschmidt CH, Rae-Grant AD. Diagnosis and Treatment of Multiple Sclerosis: A Review. JAMA. 2021 Feb 23;325(8):765-779. doi: 10.1001/jama.2020.26858.'}, {'pmid': '35666142', 'type': 'BACKGROUND', 'citation': 'Mai AS, Yong JH, Lim OZH, Tan EK. Non-invasive electrical stimulation in patients with neurodegenerative ataxia and spasticity: A systematic review and meta-analysis of randomized controlled trials. Eur J Neurol. 2022 Sep;29(9):2842-2850. doi: 10.1111/ene.15438. Epub 2022 Jun 27.'}, {'pmid': '23617555', 'type': 'BACKGROUND', 'citation': 'Learmonth YC, Motl RW, Sandroff BM, Pula JH, Cadavid D. Validation of patient determined disease steps (PDDS) scale scores in persons with multiple sclerosis. BMC Neurol. 2013 Apr 25;13:37. doi: 10.1186/1471-2377-13-37.'}, {'pmid': '39954116', 'type': 'BACKGROUND', 'citation': 'Jones AA, Purohit R, Bhatt T, Motl RW. Maintaining Mobility and Balance in Multiple Sclerosis: A Systematic Review Examining Potential Impact of Symptomatic Pharmacotherapy. CNS Drugs. 2025 Apr;39(4):361-382. doi: 10.1007/s40263-025-01159-7. Epub 2025 Feb 15.'}, {'pmid': '37949093', 'type': 'BACKGROUND', 'citation': 'Jakimovski D, Bittner S, Zivadinov R, Morrow SA, Benedict RH, Zipp F, Weinstock-Guttman B. Multiple sclerosis. Lancet. 2024 Jan 13;403(10422):183-202. doi: 10.1016/S0140-6736(23)01473-3. Epub 2023 Nov 7.'}, {'pmid': '33643662', 'type': 'BACKGROUND', 'citation': 'Hvid LG, Gaemelke T, Dalgas U, Slipsager MK, Rasmussen PV, Petersen T, Norgaard M, Skjerbaek AG, Boesen F. Personalised inpatient multidisciplinary rehabilitation elicits clinically relevant improvements in physical function in patients with multiple sclerosis - The Danish MS Hospitals Rehabilitation Study. Mult Scler J Exp Transl Clin. 2021 Feb 17;7(1):2055217321989384. doi: 10.1177/2055217321989384. eCollection 2021 Jan-Mar.'}, {'pmid': '12525714', 'type': 'BACKGROUND', 'citation': 'Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. doi: 10.1212/wnl.60.1.31.'}, {'pmid': '38354212', 'type': 'BACKGROUND', 'citation': 'Hahn A, Moeller S, Schlausch A, Ekmann M, de Chelle G, Westerlund M, Braatz F, Mayr W. Effects of a full-body electrostimulation garment application in a cohort of subjects with cerebral palsy, multiple sclerosis, and stroke on upper motor neuron syndrome symptoms. Biomed Tech (Berl). 2023 Sep 12;69(1):49-59. doi: 10.1515/bmt-2023-0271. Print 2024 Feb 26.'}, {'pmid': '21952098', 'type': 'BACKGROUND', 'citation': 'Gijbels D, Dalgas U, Romberg A, de Groot V, Bethoux F, Vaney C, Gebara B, Medina CS, Maamagi H, Rasova K, de Noordhout BM, Knuts K, Feys P. Which walking capacity tests to use in multiple sclerosis? A multicentre study providing the basis for a core set. Mult Scler. 2012 Mar;18(3):364-71. doi: 10.1177/1352458511420598. Epub 2011 Sep 27.'}, {'pmid': '28206826', 'type': 'BACKGROUND', 'citation': 'Feys P, Lamers I, Francis G, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. The Nine-Hole Peg Test as a manual dexterity performance measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):711-720. doi: 10.1177/1352458517690824. Epub 2017 Feb 16.'}, {'type': 'BACKGROUND', 'citation': 'Feys, P., Moghames, P., Kasilingam, E., King, R., Manacorda, T., Fonseca, M., Notas, K., & Kos, D. (2024). Prevalence, severity and impact of MS symptoms, and use of services in Europe: Results from the large scale IMSS survey. Multiple Sclerosis Journal, 30(3S), 1160.'}, {'pmid': '21779953', 'type': 'BACKGROUND', 'citation': 'Cameron MH, Wagner JM. Gait abnormalities in multiple sclerosis: pathogenesis, evaluation, and advances in treatment. Curr Neurol Neurosci Rep. 2011 Oct;11(5):507-15. doi: 10.1007/s11910-011-0214-y.'}, {'pmid': '29260609', 'type': 'BACKGROUND', 'citation': 'Callesen J, Richter C, Kristensen C, Sunesen I, Naesby M, Dalgas U, Skjerbaek AG. Test-retest agreement and reliability of the Six Spot Step Test in persons with multiple sclerosis. Mult Scler. 2019 Feb;25(2):286-294. doi: 10.1177/1352458517745725. Epub 2017 Dec 20.'}, {'pmid': '29220753', 'type': 'BACKGROUND', 'citation': 'Buckley E, Mazza C, McNeill A. A systematic review of the gait characteristics associated with Cerebellar Ataxia. Gait Posture. 2018 Feb;60:154-163. doi: 10.1016/j.gaitpost.2017.11.024. Epub 2017 Dec 1.'}, {'pmid': '28984159', 'type': 'BACKGROUND', 'citation': 'Boesen F, Norgaard M, Trenel P, Rasmussen PV, Petersen T, Lovendahl B, Sorensen J. Longer term effectiveness of inpatient multidisciplinary rehabilitation on health-related quality of life in MS patients: a pragmatic randomized controlled trial - The Danish MS Hospitals Rehabilitation Study. Mult Scler. 2018 Mar;24(3):340-349. doi: 10.1177/1352458517735188. Epub 2017 Oct 6.'}, {'pmid': '19397800', 'type': 'BACKGROUND', 'citation': 'Bharmal M, Payne K, Atkinson MJ, Desrosiers MP, Morisky DE, Gemmen E. Validation of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on antihypertensive medications. Health Qual Life Outcomes. 2009 Apr 27;7:36. doi: 10.1186/1477-7525-7-36.'}, {'pmid': '39497494', 'type': 'BACKGROUND', 'citation': 'Amatya B, Khan F, Song K, Galea M. Effectiveness of Non-Pharmacological Interventions for Spasticity Management in Multiple Sclerosis: A Systematic Review. Ann Rehabil Med. 2024 Oct;48(5):305-343. doi: 10.5535/arm.240064. Epub 2024 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'This study is being carried out at Multiple Sclerosis (MS) centers to evaluate whether a full-body stimulation suit at home can help people with Multiple Sclerosis (pwMS) reduce symptoms like spasticity (muscle stiffness) and ataxia (poor coordination), and improve daily functioning.\n\nCan pwMS who experience spasticity or ataxia benefit from using a stimulation suit for 6 weeks?\n\nResearchers will compare two groups: an intervention group (who will use the suit) and a control group (who will not use the suit).\n\nParticipants in the intervention group will:\n\n* Wear the suit for 6 weeks in total every day or every other day (1 week during their MS center admission and 5 weeks at home).\n* Receive their usual care in addition to wearing the suit.\n* Undergo clinical tests at the MS center after 1 week and 6 weeks of stimulation.\n\nParticipants in the control group will:\n\n* Receive their usual care.\n* Undergo clincial tests at the same time points as the other group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible participants must have ataxia or spasticity alongside impairments in upper or lower extremity physical function. MAS score ≥ 1 will be used as an inclusion criterion to determine the presence of spasticity. SARA score ≥ 4 will be used as an inclusion criterion to determine the presence of ataxia. Note: one of the two criteria (MAS score or SARA score) must be fulfilled for a pwMS to be eligible.\n* The patient must have the cognitive abilities to understand instructions and to be able to complete the questionnaires adequately\n* Diagnosis of multiple sclerosis.\n\nExclusion Criteria:\n\n* Implanted devices (like pacemaker, Baclofen pump, neurostimulator, defibrillator, shunts, ECG equipment, electronic life support, high frequency operation equipment )\n* Change in disease modifying treatment within the last 3 months\n* Use of Botuline Toxine A within the last 3months\n* Recent relapse within the last 3 months\n* Acute musculoskeletal problems that hinder the test performance,\n* Pregnancy\n* Sizes bigger than 3XL (triple eXtra Large)\n* Skin eruptions and/or skin areas in the stimulation zone that are swollen, infected or inflamed.'}, 'identificationModule': {'nctId': 'NCT07202195', 'acronym': 'HANDS-MS', 'briefTitle': 'At Home Use of Stimulation Suits for Managing MS Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Home-Based Neuromodulation Suits for Reducing Spasticity and Ataxia in Multiple Sclerosis: A Multi-center RCT', 'orgStudyIdInfo': {'id': 'J5812540_2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stimulation suit group', 'description': 'This group will wear a full-body stimulation suit every day or every other day for six weeks, in addition to their usual care.', 'interventionNames': ['Device: electro-stimulation suit', 'Other: Usual Care']}, {'type': 'OTHER', 'label': 'usual care', 'description': 'This group will be a comparator and have no added intervention expect for their usual care.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'electro-stimulation suit', 'type': 'DEVICE', 'otherNames': ['neuromodulation suit', 'stimulation suit', 'EXOPULSE MOLLII suit'], 'description': 'In EXOPULSE Mollii Suit is a multi-channel full-body suit with a low energy electrical stimulation - 20 Volt and 20 Hz. It generates 2 milliamp pulses (into 0-10,000 Ohms) with the following parameters:\n\n* Pulse width: variable between 25 and 170 μs.\n* Length of period: 50 ms.\n* Maximum amplitude: 20 V. It is composed of a control unit, a jacket and pants, with 58 embed-ded electrodes, in direct contact with the skin, and pre-positioned to stimulate 40 key muscle groups.\n\nThe suit comes in different sizes. A trained medical staff pre-programs which nerves/muscles to be stimulated based on a clinical assessment of the user and the outcome is evaluated through standardized methods. The stimulation program is thus specific to each user.', 'armGroupLabels': ['stimulation suit group']}, {'name': 'Usual Care', 'type': 'OTHER', 'otherNames': ['standard care'], 'description': 'The rehabilitation therapy that is being offered at the National MS Center Melsbroek, but somewhat reduced/adjusted to make time for initiation and follow-up of using the neuromodulation suit and potentially also during the weeks at home (i.e., rehabilitation being offered by municipalities).', 'armGroupLabels': ['stimulation suit group', 'usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1820', 'city': 'Steenokkerzeel', 'country': 'Belgium', 'contacts': [{'name': 'Daphne Kos', 'role': 'CONTACT', 'email': 'daphne.kos@uzbrussel.be', 'phone': '+32496107849'}, {'name': 'Alix-Anne Schreinemacher', 'role': 'CONTACT', 'email': 'alix-anne.schreinemacher@mscenter.be'}, {'name': 'Daphne Kos', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': "Miguel D'Haeseleer", 'role': 'SUB_INVESTIGATOR'}, {'name': 'Famke Vanderhauweraert', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alix-Anne Schreinemacher', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Nationaal MS Center Melsbroek', 'geoPoint': {'lat': 50.91851, 'lon': 4.50989}}, {'zip': '8680', 'city': 'Ry', 'country': 'Denmark', 'contacts': [{'name': 'Lars Hvid', 'role': 'CONTACT', 'email': 'LARSHV@sclerosehospital.dk'}], 'facility': 'The Danish MS Hospitals', 'geoPoint': {'lat': 56.09038, 'lon': 9.76505}}], 'centralContacts': [{'name': 'Daphne Kos', 'role': 'CONTACT', 'email': 'daphne.kos@uzbrussel.be', 'phone': '+32496107849'}, {'name': 'Alix-Anne Schreinemacher', 'role': 'CONTACT', 'email': 'alix-anne.schreinemacher@mscenter.be'}], 'overallOfficials': [{'name': 'Daphne Kos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daphne Kos', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish MS Hospitals, Haslev and Ry', 'class': 'OTHER'}, {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, {'name': 'National MS Center Melsbroek', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Daphne Kos', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}