[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05584124":3,"trial-entities:NCT05584124":116,"trial-summary:NCT05584124":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":46,"secondary_outcomes":51,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":15,"eligibility_criteria":63,"std_ages":76,"locations":79,"central_contacts":104,"overall_officials":112,"references":114,"see_also_links":115},"NCT05584124","N3790-W","Repetitive Transcranial Magnetic Stimulation, a Form of Non-invasive Brain Stimulation, as a Possible Treatment for Post-stroke Fatigue.","Neuromodulation for Rehabilitation of Post-Stroke Fatigue: An rTMS Pilot Study","RECRUITING","2027-10-29","2026-04","2026-04-21","2023-04-10","VA Office of Research and Development","FED",false,"This experimental trial is investigating the use of magnetic stimulation of the brain as a possible treatment for post-stroke fatigue in people who have had a stroke more than six months prior to enrolling. Fatigue is a common condition after a stroke and can negatively impact an individual's ability to perform desired social and physical activities. Magnetic stimulation of the brain has been shown to improve signs and symptoms of related psychological (e.g., depression) conditions. Participants in this trial will receive a type of magnetic stimulation called repetitive transcranial magnetic stimulation, or rTMS. The investigators will measure feelings of fatigue and other clinical characteristics related to mood and cognition before and after participants receive rTMS.","The PI for this trial transferred to the Atlanta VA Medical Center in Feb 2026. As a result, the trial was suspended at the original site and moved to the Atlanta area. Additional changes accompanying the site transfer include removing one arm of the study (an active comparator), leaving two arms: one with the active treatment and the other with a sham treatment. Eligibility criteria were also updated to be more ecologically relevant. Ethical approvals for the new site, Atlanta, were provided by the Emory University IRB.",[19,20,21],"Stroke","Stroke, Chronic","Fatigue",[23,24,25,26,27],"non-invasive brain stimulation","post-stroke fatigue","perception of fatigue","repetitive transcranial magnetic stimulation","rTMS","INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},60,"ESTIMATED",[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DEVICE","High frequency repetitive transcranial magnetic stimulation","MagVenture MagPro X100 with MagOption",[41],"Real M1 High Frequency rTMS",{"type":37,"name":43,"description":39,"armGroupLabels":44},"Sham repetitive transcranial magnetic stimulation",[45],"Sham rTMS",[47],{"measure":48,"description":49,"timeFrame":50},"Change in Fatigue Severity Scale (FSS) score","The Fatigue Severity Scale (FSS) is a patient reported outcome measure assessing perceived influence of fatigue over the past week. The scale consists of nine questions measured on a 7-point Likert scale (1-7). The FSS' range of scores is from 9 (min) to 63 (max) with lower numbers representing lower\u002Fless impact of fatigue.","Change from baseline FSS score to 7 days after last treatment",[52,56,58],{"measure":53,"description":54,"timeFrame":55},"Change in Modified Fatigue Impact Scale (MFIS) score","The Modified Fatigue Impact Scale (MFIS) is a Patient reported outcome assessing the impact of fatigue over the past four weeks. The questionnaire is comprised of 21 questions covering three domains (physical, cognitive, and psychosocial subscales). The assessment is graded on a 5 point Likert scale (0-4). The MFIS' range of scores is from 0-84 with higher scores indicating greater impact\u002Fworse fatigue. The range of scores for the physical, cognitive, and psychosocial subscales are 0-36, 0-40, and 0-8 respectively. Greater scores indicate greater\u002Fworse impact of fatigue.","Change from baseline MFIS score to 7 Days after last treatment",{"measure":48,"description":49,"timeFrame":57},"Change from baseline FSS score to 3 months after last treatment",{"measure":53,"description":54,"timeFrame":59},"Change from baseline MFIS score to 3 months after last treatment","ALL","34 Years","80 Years",{"inclusion":64,"exclusion":68,"raw_text":75},[65,66,67],"34 - 80 years of age","more than 6 months post-stroke","Clinically present fatigue",[69,70,71,72,73,72,74],"Contraindications to MRI\u002FTMS\u002FrTMS (e.g. implanted metal within the head, history of seizures)","Inability to follow simple three-step instructions","Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, moderate\u002Fsevere TBI)","Pregnancy","strokes within stimulation sites","Severe hypertension (resting SBP \\> 200, DBP \\> 120)","Inclusion Criteria:\n\n* 34 - 80 years of age\n* more than 6 months post-stroke\n* Clinically present fatigue\n\nExclusion Criteria:\n\n* Contraindications to MRI\u002FTMS\u002FrTMS (e.g. implanted metal within the head, history of seizures)\n* Inability to follow simple three-step instructions\n* Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, moderate\u002Fsevere TBI)\n* Pregnancy\n* strokes within stimulation sites\n* Pregnancy\n* Severe hypertension (resting SBP \\> 200, DBP \\> 120)",[77,78],"ADULT","OLDER_ADULT",[80],{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":101},"Atlanta VA Medical and Rehab Center, Decatur, GA","Decatur","Georgia","30033-4004","United States",[87,93,98],{"name":88,"role":89,"phone":90,"phoneExt":91,"email":92},"Medina O Bello","CONTACT","404-321-6111","206967","medina.bello@va.gov",{"name":94,"role":89,"phone":95,"phoneExt":96,"email":97},"Kevin Mammino","(404) 432-6111","205396","kevin.mammino@va.gov",{"name":99,"role":100},"John H Kindred","PRINCIPAL_INVESTIGATOR",{"lat":102,"lon":103},33.77483,-84.29631,[105,108],{"name":99,"role":89,"phone":106,"email":107},"(970) 426-9350","John.Kindred1@va.gov",{"name":109,"role":89,"phone":95,"phoneExt":110,"email":111},"Christina Young","207670","christina.young3@va.gov",[113],{"name":99,"affiliation":81,"role":100},[],[],{"nct_id":4,"conditions":117,"biomarkers":118},[21,19],[],{"nct_id":4,"found":120,"summary":121,"prompt_version":131},true,{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This interventional study plans to enroll 60 participants. It compares active repetitive transcranial magnetic stimulation (rTMS) with a sham (inactive) rTMS treatment.","completed","Repetitive Transcranial Magnetic Stimulation for Post-Stroke Fatigue","This study is looking into whether repetitive transcranial magnetic stimulation (rTMS), a type of non-invasive brain stimulation, can help people with fatigue after a stroke. Fatigue is a common problem after a stroke and can make daily activities difficult. You might be able to join if you are between 34 and 80 years old, had a stroke more than six months ago, and experience fatigue. The study will measure how much your fatigue changes using a scale called the Fatigue Severity Scale (FSS) seven days after your last treatment. The study is currently unclear on its recruitment status, but it aims to enroll 60 participants.","Your fatigue will be measured seven days after your last treatment.",105,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]