[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07688551":3,"trial-entities:NCT07688551":180,"trial-summary:NCT07688551":183},{"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":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":30,"interventions":33,"primary_outcomes":41,"secondary_outcomes":46,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":92,"locations":95,"central_contacts":154,"overall_officials":161,"references":162,"see_also_links":179},"NCT07688551","STUDY00000004","Superiority Trial of Aphasia-focused Rehabilitation With tDCS Stimulation","Transcranial Direct Current Stimulation to Treat Aphasia: A Superiority Study","RECRUITING","2030-06","2026-07","2026-07-21","2026-07-14","University of South Carolina","OTHER",true,"The purpose of this study is to help us understand if adding transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, to Speech Therapy improves language recovery in people with Broca's aphasia and is more effective than Speech Therapy alone.","This project is a prospective randomized controlled double-blinded clinical trial to compare auditory-visual speech therapy coupled with adjuvant active anodal tDCS (A-tDCS) versus speech therapy coupled with sham tDCS (S-tDCS). The investigators will perform an adaptive Phase II\u002FIII design, in which the first portion of the study (Phase II) will determine the optimal dose of A-tDCS (1 mA versus 2 mA) and provide a go\u002Fno-go decision for Phase III. The investigators will use a 10-10 system to determine electrode placement, with 5 x 5 cm pads, and stimulation duration will be 20 minutes. Phase III will test the definitive superiority of adjuvant A-tDCS at the optimal dose coupled with speech therapy versus speech therapy alone (S-tDCS) to improve naming among individuals with chronic Broca's aphasia.",[19,20],"Aphasia","Broca's Aphasia",[22,23,19,24],"tDCS","STARS","Stroke","INTERVENTIONAL","TREATMENT",[28,29],"PHASE2","PHASE3",{"count":31,"type":32},130,"ESTIMATED",[34],{"type":35,"name":22,"description":36,"armGroupLabels":37},"DEVICE","The study intervention will be delivered using the Soterix 1x1 Transcranial Electrical Stimulation Clinical Trials device (Soterix Medical Inc., New York).",[38,39,40],"1 mA A-tDCS","2 mA A-tDCS","S-tDCS",[42],{"measure":43,"description":44,"timeFrame":45},"Naming","Change in the number of correctly named items between the average of the two pre-treatment Philadelphia Naming Test (PNT) assessments and the average of the two post-treatment PNT sessions at 4-weeks post treatment.","From baseline assessment to 4-weeks post treatment",[47,50,53,56,59,62,65],{"measure":43,"description":48,"timeFrame":49},"To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving naming at 1-week post treatment.","From baseline assessment to 1-week post treatment",{"measure":43,"description":51,"timeFrame":52},"To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving naming at 24-weeks post treatment.","From baseline assessment to 24-weeks post treatment",{"measure":54,"description":55,"timeFrame":45},"Aphasia Severity","To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in reducing aphasia severity as measured by the Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ).",{"measure":57,"description":58,"timeFrame":45},"Functional Communication","To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving functional communication.",{"measure":60,"description":61,"timeFrame":45},"Quality of Life","To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving quality of life as measured by the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39).",{"measure":63,"description":64,"timeFrame":45},"Communication Confidence","To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving communication confidence.",{"measure":66,"description":67,"timeFrame":45},"Safety","To demonstrate safety differences (proportion of new adverse events) between groups.","ALL","25 Years","80 Years",false,{"inclusion":73,"exclusion":82,"raw_text":91},[74,75,76,77,78,79,80,81],"Be willing and able to give informed consent.","Be willing and able to comply with study requirements.","Be between 25 and 80 years of age.","Have used English as the primary language for \\> 15 years.","Have the diagnosis of aphasia due to a left hemisphere stroke, confirmed by study physician based on past clinical MRI scan or research scan.","Be greater than 6 months post-stroke.","Have Broca's aphasia diagnosed by the WAB-R (fluency score ≤ 5, auditory verbal comprehension score 4-10, repetition score 0-7.9, naming and word finding score \\\u003C 9).","Correctly name 140 or fewer items on the PNT.",[83,84,85,86,87,88,89,90],"History of brain surgery except for during the treatment of the acute stroke.","Seizures during the previous 12-months.","Compromised skin at or near electrode sites (e.g., rash, eczema, wounds, infection).","Correctly name more than 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test).","Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) score of 25 or below.","Participants with open skull defects (e.g., greater than 1 cm) in the area underneath the anode electrode positioning or participants with metal implants or electrical stimulators.","Participants with continuous oxygen therapy which cannot be discontinued for more than 1 hour.","Any condition or situation that the PI determines would significantly interfere with the participant's ability to complete the study.","Inclusion Criteria:\n\n* Be willing and able to give informed consent.\n* Be willing and able to comply with study requirements.\n* Be between 25 and 80 years of age.\n* Have used English as the primary language for \\> 15 years.\n* Have the diagnosis of aphasia due to a left hemisphere stroke, confirmed by study physician based on past clinical MRI scan or research scan.\n* Be greater than 6 months post-stroke.\n* Have Broca's aphasia diagnosed by the WAB-R (fluency score ≤ 5, auditory verbal comprehension score 4-10, repetition score 0-7.9, naming and word finding score \\\u003C 9).\n* Correctly name 140 or fewer items on the PNT.\n\nExclusion Criteria:\n\n* History of brain surgery except for during the treatment of the acute stroke.\n* Seizures during the previous 12-months.\n* Compromised skin at or near electrode sites (e.g., rash, eczema, wounds, infection).\n* Correctly name more than 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test).\n* Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) score of 25 or below.\n* Participants with open skull defects (e.g., greater than 1 cm) in the area underneath the anode electrode positioning or participants with metal implants or electrical stimulators.\n* Participants with continuous oxygen therapy which cannot be discontinued for more than 1 hour.\n* Any condition or situation that the PI determines would significantly interfere with the participant's ability to complete the study.",[93,94],"ADULT","OLDER_ADULT",[96,117,139],{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":114},"Medical University of South Carolina","Charleston","South Carolina","29425","United States",[103,108,111],{"name":104,"role":105,"phone":106,"email":107},"Stephanie Cute","CONTACT","843-548-7041","cute@musc.edu",{"name":109,"role":110},"Janina Wilmskoetter","PRINCIPAL_INVESTIGATOR",{"name":112,"role":113},"Christy Cassarly","SUB_INVESTIGATOR",{"lat":115,"lon":116},32.77632,-79.93275,{"facility":13,"status":8,"city":118,"state":99,"zip":119,"country":101,"contacts":120,"geoPoint":136},"Columbia","29201",[121,124,126,128,130,132,134],{"name":122,"role":105,"email":123},"Allison Hare","allison.hare@sc.edu",{"name":125,"role":110},"Leonardo Bonilha",{"name":127,"role":110},"Julius Fridriksson",{"name":129,"role":113},"Chris Rorden",{"name":131,"role":113},"Roger Newman-Norlund",{"name":133,"role":113},"James Hardin",{"name":135,"role":113},"Samaneh Nemati",{"lat":137,"lon":138},34.00071,-81.03481,{"facility":140,"status":8,"city":141,"state":142,"zip":143,"country":101,"contacts":144,"geoPoint":151},"University of Utah","Salt Lake City","Utah","84112",[145,148,149],{"name":146,"role":105,"email":147},"Robert Kraemer","Robert.Kraemer@hsc.utah.edu",{"name":146,"role":110},{"name":150,"role":113},"Julie Wambaugh",{"lat":152,"lon":153},40.76078,-111.89105,[155,158],{"name":125,"role":105,"phone":156,"email":157},"803-216-3469","Leonardo.Bonilha@uscmed.sc.edu",{"name":127,"role":105,"phone":159,"email":160},"803-777-5931","fridriks@mailbox.sc.edu",[],[163,167,170,173,176],{"pmid":164,"type":165,"citation":166},"20395612","BACKGROUND","Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161\u002FSTROKEAHA.109.576785. Epub 2010 Apr 15.",{"pmid":168,"type":165,"citation":169},"30128538","Fridriksson J, Rorden C, Elm J, Sen S, George MS, Bonilha L. Transcranial Direct Current Stimulation vs Sham Stimulation to Treat Aphasia After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2018 Dec 1;75(12):1470-1476. doi: 10.1001\u002Fjamaneurol.2018.2287.",{"pmid":171,"type":165,"citation":172},"30318184","Fridriksson J, Basilakos A, Stark BC, Rorden C, Elm J, Gottfried M, George MS, Sen S, Bonilha L. Transcranial direct current stimulation to treat aphasia: Longitudinal analysis of a randomized controlled trial. Brain Stimul. 2019 Jan-Feb;12(1):190-191. doi: 10.1016\u002Fj.brs.2018.09.016. Epub 2018 Sep 29. No abstract available.",{"pmid":174,"type":165,"citation":175},"33719732","Wilmskoetter J, Fridriksson J, Basilakos A, Phillip Johnson L, Marebwa B, Rorden C, Warner G, Hickok G, Hillis AE, Bonilha L. Indirect White Matter Pathways Are Associated With Treated Naming Improvement in Aphasia. Neurorehabil Neural Repair. 2021 Apr;35(4):346-355. doi: 10.1177\u002F1545968321999052. Epub 2021 Mar 10.",{"pmid":177,"type":165,"citation":178},"38071545","Bonilha L, Rorden C, Roth R, Sen S, George MS, Fridriksson J. Improved naming in patients with Broca's aphasia with tDCS. J Neurol Neurosurg Psychiatry. 2024 Feb 14;95(3):273-276. doi: 10.1136\u002Fjnnp-2023-331541.",[],{"nct_id":4,"conditions":181,"biomarkers":182},[20],[],{"nct_id":4,"found":15,"summary":184,"prompt_version":194},{"design":185,"status":186,"heading":187,"summary":188,"follow_up":189,"word_count":190,"commitments":191,"compensation":192,"drugs_mentioned":193},"This is a randomized, controlled, and double-blinded study, meaning participants are assigned to groups by chance, there's a comparison group, and neither you nor your doctors will know which treatment you are receiving. It's an adaptive Phase II\u002FIII study, aiming to enroll 130 participants.","completed","Aphasia Rehabilitation with tDCS Stimulation","This study is investigating if adding transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, to speech therapy can better improve language recovery in people with Broca's aphasia (a type of aphasia affecting speech production) compared to speech therapy alone. Researchers will compare speech therapy with active tDCS using the Soterix 1x1 Transcranial Electrical Stimulation Clinical Trials device, to speech therapy with a sham (inactive) tDCS. The main goal is to see if this combination improves naming ability over 4 weeks after treatment. The study plans to enroll 130 participants between 25 and 80 years old who have aphasia from a left hemisphere stroke and have used English as their primary language for over 15 years. The current recruitment status is unclear.","Your naming ability will be measured from the start of the study until 4 weeks after your treatment ends.",123,"Not specified in the trial record.","Not stated in the trial record.",[22],"v2"]