[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07534397":3,"trial-entities:NCT07534397":197,"trial-summary:NCT07534397":201},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":53,"secondary_outcomes":69,"sex":119,"minimum_age":120,"maximum_age":121,"healthy_volunteers":14,"eligibility_criteria":122,"std_ages":163,"locations":166,"central_contacts":187,"overall_officials":190,"references":195,"see_also_links":196},"NCT07534397","IRB-26-35","Treatment of Cognitive and Sensorimotor Deficits in Parkinson's Disease With High Definition Transcranial Direct Current Stimulation","RECRUITING","2027-10-31","2026-06","2026-09-16","2026-09-15","The University of Texas at Dallas","OTHER",false,"The purpose of this research study is to examine the effects of transcranial Direct Current Stimulation (tDCS) on verbal retrieval and cognition and sensorimotor control and to determine if tDCS can be used as a way to improve retrieval, sensory, and motor abilities in individuals with Parkinson's disease (PD).","Objective: Based on models of semantic memory retrieval developed, under which the pre-supplementary motor area (preSMA) of the dorsomedial frontal lobes play an important role, the study will examine the treatment of cognitive deficits in PD with HD tDCS applied to the preSMA to improve function in neural circuits supporting verbal retrieval. In addition, as the preSMA is implicated in motor planning and sequencing, the study also will explore whether HD tDCS applied to the preSMA will have an effect on speech and gait.\n\nSpecific Aims:\n\n1. Examine the therapeutic effects on verbal retrieval function by modulating the preSMA using HD tDCS.\n2. Examine the therapeutic effects on speech production and processing by modulating the preSMA using HD tDCS\n3. Examine the therapeutic effects on gait and balance by modulating the preSMA using HD tDCS\n\nHypotheses:\n\n1. : Active HD tDCS (1 ma anodal HD tDCS to the preSMA compared to sham) will improve verbal fluency (i.e, phonemic and category fluency on Controlled Word Association Test) as primary outcome measures.\n2. : Active HD tDCS (1 ma anodal HD tDCS to the preSMA compared to sham) will improve speech sequencing.\n3. : Active HD tDCS (1 ma anodal HD tDCS to the preSMA compared to sham) will improve general motor sequencing",[18],"PARKINSON DISEASE (Disorder)",[20,21,22,23,24,25,26],"transcranial direct current stimulation (tDCS)","Parkinson's Disease","electroencephalography (EEG)","presupplementary motor area (preSMA)","verbal memory","speech sequencing","motor sequencing","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},20,"ESTIMATED",[35,45],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":41},"DEVICE","transcranial direct current stimulation","Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10\u002F10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag\u002FAgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.",[40],"Transcranial direct current stimulation",[42,43,44],"transcranial electric stimulation","tDCS","tES",{"type":36,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Sham transcranial direct current stimulation","Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10\u002F10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag\u002FAgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.",[46],[50,51,52],"sham tDCS","Sham trascranial electric stimulation","sham tES",[54,58,62,65],{"measure":55,"description":56,"timeFrame":57},"Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency","valuation of treatment group differences in change on Category Fluency from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)","Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment",{"measure":59,"description":60,"timeFrame":61},"Treatment group differences in change from Baseline to 2-months Post-Treatment on Category Fluency","Evaluation of treatment group differences in change on Category Fluency from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)","Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment",{"measure":63,"description":64,"timeFrame":57},"Treatment group differences in change from Baseline to 1-week Post-Treatment on Phonemic Fluency","Evaluation of treatment group differences in change on Phonemic Fluency from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)",{"measure":66,"description":67,"timeFrame":68},"Treatment group differences in change from Baseline to 2-months Post-Treatment on Phonemic Fluency","Evaluation of treatment group differences in change on Phonemic Fluency from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated (minimum=0 words; no maximum)","Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment",[70,73,77,80,83,86,89,92,95,98,101,104,107,110,113,116],{"measure":71,"description":72,"timeFrame":57},"Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rate during overt reading","Evaluation of treatment group differences in change in speaking rate from baseline to 1-week post-treatment. Metric: syllables per second on a passage reading task (minimum=0; no maximum).",{"measure":74,"description":75,"timeFrame":76},"Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rate during overt reading","Evaluation of treatment group differences in change on speaking rate from baseline to 2-months post-treatment. Metric: Syllables per second during a reading passage (minimum=0; no maximum).","Outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-months Post-Treatment",{"measure":78,"description":79,"timeFrame":57},"Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rate during self-generated speech","Evaluation of treatment group differences in change in speaking rate from baseline to 1-week post-treatment. Metric: Syllables per second during self-generated speech (minimum=0; no maximum).",{"measure":81,"description":82,"timeFrame":76},"Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rate during self-generated speech","Evaluation of treatment group differences in change on speaking rate from baseline to 2-months post-treatment. Metric: Syllables per second during self-generated speech (minimum=0; no maximum).",{"measure":84,"description":85,"timeFrame":57},"Treatment group differences in change from Baseline to 1-week Post-treatment on Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score.","Evaluation of treatment group differences in change in Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score from baseline to 1-week post-treatment. Metric: Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score (minimum=0; maximum=132)",{"measure":87,"description":88,"timeFrame":61},"Treatment group differences in change from Baseline to 2-month Post-treatment on Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score.","Evaluation of treatment group differences in change in Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score from baseline to 2-month post-treatment. Metric: Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale Part III score (minimum=0; maximum=132)",{"measure":90,"description":91,"timeFrame":57},"Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rhythm during overt reading","Evaluation of treatment group differences in change in speaking rhythm from baseline to 1-week post-treatment. Metric: coefficient of variation of syllable duration on a passage reading task (minimum=0; no maximum).",{"measure":93,"description":94,"timeFrame":76},"Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rhythm during overt reading","Evaluation of treatment group differences in change on speaking rhythm from baseline to 2-months post-treatment. Metric: Coefficient of variation of syllable duration during a reading passage (minimum=0; no maximum).",{"measure":96,"description":97,"timeFrame":57},"Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Rhythm during self-generated speech","Evaluation of treatment group differences in change in speaking rhythm from baseline to 1-week post-treatment. Metric: Coefficient of variation of syllable duration during self-generated speech (minimum=0; no maximum).",{"measure":99,"description":100,"timeFrame":76},"Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Rhythm during self-generated speech","Evaluation of treatment group differences in change on speaking rhythm from baseline to 2-months post-treatment. Metric: Coefficient of variation of syllable duration during self-generated speech (minimum=0; no maximum).",{"measure":102,"description":103,"timeFrame":57},"Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Pause Time during overt reading","Evaluation of treatment group differences in change in speaking pause time from baseline to 1-week post-treatment. Metric: Pause time as percentage of total speaking time on a passage reading task (minimum=0%; maximum=100%).",{"measure":105,"description":106,"timeFrame":76},"Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Pause Time during overt reading","Evaluation of treatment group differences in change on speaking pause time from baseline to 2-months post-treatment. Metric: Pause time as percentage of total speaking time during a reading passage (minimum=0%; maximum=100%).",{"measure":108,"description":109,"timeFrame":57},"Treatment group differences in change from Baseline to 1-week Post-treatment on Speaking Pause Time during self-generated speech","Evaluation of treatment group differences in change in speaking pause time from baseline to 1-week post-treatment. Metric: Pause time as percentage of total speaking time during self-generated speech (minimum=0%; maximum=100%).",{"measure":111,"description":112,"timeFrame":76},"Treatment group differences in change from Baseline to 2-months Post-Treatment on Speaking Pause Time during self-generated speech","Evaluation of treatment group differences in change on speaking pause time from baseline to 2-months post-treatment. Metric: Pause time as percentage of total speaking time during self-generated speech (minimum=0%; maximum=100%).",{"measure":114,"description":115,"timeFrame":57},"Treatment group differences in change from Baseline to 1-week Post-treatment on Freezing of Gate during the timed up and go task","Evaluation of treatment group differences in change in freezing of gate from baseline to 1-week post-treatment. Metric: Timed up and go time (minimum=0; no maximum).",{"measure":117,"description":118,"timeFrame":61},"Treatment group differences in change from Baseline to 2-month Post-treatment on Freezing of Gate during the timed up and go task","Evaluation of treatment group differences in change in freezing of gate from baseline to 2-month post-treatment. Metric: Timed up and go time (minimum=0; no maximum).","ALL","50 Years","90 Years",{"inclusion":123,"exclusion":128,"raw_text":162},[124,125,126,127],"Diagnosed with PD having a verbal fluency deficit based on neuropsychological test (T-score \\\u003C 40 or a T-score \\\u003C-1.0 SD below the average T-score): Semantic Object Retrieval Test (SORT), COWAT (both letter and category fluency), Boston Naming Test (BNT), Rey Auditory Verbal Learning Test (RAVLT)","50 - 90 years old","Capable of understanding and signing an informed consent (able to answer consent comprehension questions)","Fluent in speaking and reading English",[129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161],"Montreal Cognitve Assessment (MOCA) score \\\u003C23, unless an accompanying study partner\u002Fcaregiver is with them and we can obtain the written consent of both the participant and the participant's accompanying study partner\u002Fcaregiver (i.e., the participant's spouse, adult child, parent, or adult sibling);","history of seizures;","unexplained episodes of loss of consciousness (as these may be related to brain alterations or epilepsy);","suffering from severe or frequent headaches;","unstable or uncontrolled neuropsychiatric illness;","severe traumatic brain injury (based on the Ohio State TBI Identification; Method);","brain tumor; stroke; present drug abuse\u002Fmisuse;","brain tumor;","serious or life-threatening diseases, including congestive heart failure, chronic obstructive pulmonary disease, or active malignancy;","Huntington's disease;","stroke;","cranial implants or skull defects that affect tDCS administration;","implanted brain medical devices, including, deep brain stimulators (DBS);","implanted pacemakers;","any electrically, magnetically, or mechanically activated implants;","cardiac, neural, or medication implants;","vascular clips or other electrically sensitive support systems in the brain;","damaged skin at the sites of stimulation (the device should only be used on healthy, intact skin, as wounds may alter resistance to current);","skin conditions such as dermatitis, psoriasis, or eczema;","pregnant women;","diagnosis of just dysarthria;","anti-convulsants;","carbamazepine;","sulpiride;","pergolide;","lorazepam;","rivastigmine;","dextromethorphan;","D-cycloserine;","flunarizine;","ropinirole;","citalopram;","stimulants;","Inclusion Criteria:\n\n* Diagnosed with PD having a verbal fluency deficit based on neuropsychological test (T-score \\\u003C 40 or a T-score \\\u003C-1.0 SD below the average T-score): Semantic Object Retrieval Test (SORT), COWAT (both letter and category fluency), Boston Naming Test (BNT), Rey Auditory Verbal Learning Test (RAVLT)\n* 50 - 90 years old\n* Capable of understanding and signing an informed consent (able to answer consent comprehension questions)\n* Fluent in speaking and reading English\n\nExclusion Criteria:\n\nA potentially study-confounding, tDCS-contraindicated, or EEG-contraindicated psychological, neuropsychiatric, neurological, or other medical issues:\n\n* Montreal Cognitve Assessment (MOCA) score \\\u003C23, unless an accompanying study partner\u002Fcaregiver is with them and we can obtain the written consent of both the participant and the participant's accompanying study partner\u002Fcaregiver (i.e., the participant's spouse, adult child, parent, or adult sibling);\n* history of seizures;\n* unexplained episodes of loss of consciousness (as these may be related to brain alterations or epilepsy);\n* suffering from severe or frequent headaches;\n* unstable or uncontrolled neuropsychiatric illness;\n* severe traumatic brain injury (based on the Ohio State TBI Identification; Method);\n* brain tumor; stroke; present drug abuse\u002Fmisuse;\n* brain tumor;\n* serious or life-threatening diseases, including congestive heart failure, chronic obstructive pulmonary disease, or active malignancy;\n* Huntington's disease;\n* stroke;\n* cranial implants or skull defects that affect tDCS administration;\n* implanted brain medical devices, including, deep brain stimulators (DBS);\n* implanted pacemakers;\n* any electrically, magnetically, or mechanically activated implants;\n* cardiac, neural, or medication implants;\n* vascular clips or other electrically sensitive support systems in the brain;\n* damaged skin at the sites of stimulation (the device should only be used on healthy, intact skin, as wounds may alter resistance to current);\n* skin conditions such as dermatitis, psoriasis, or eczema;\n* pregnant women;\n* diagnosis of just dysarthria;\n\nUse of medications that interact with or potentially interact with tDCS or EEG effects:\n\n* anti-convulsants;\n* carbamazepine;\n* sulpiride;\n* pergolide;\n* lorazepam;\n* rivastigmine;\n* dextromethorphan;\n* D-cycloserine;\n* flunarizine;\n* ropinirole;\n* citalopram;\n* stimulants;\n\nAdditionally, non-English speakers will be excluded because not all of the screening forms, questionnaires, and tests are available in languages other than English.",[164,165],"ADULT","OLDER_ADULT",[167],{"facility":168,"status":7,"city":169,"state":170,"zip":171,"country":172,"contacts":173,"geoPoint":184},"Callier Clinical Center, The University of Texas at Dallas","Richardson","Texas","75080","United States",[174,179,182],{"name":175,"role":176,"phone":177,"email":178},"Michael A Motes, PhD","CONTACT","972-883-4846","michael.motes@utd.edu",{"name":180,"role":181},"John Hart, Jr, MD","PRINCIPAL_INVESTIGATOR",{"name":183,"role":181},"Saul A Frankford, PhD",{"lat":185,"lon":186},32.94818,-96.72972,[188],{"name":175,"role":176,"phone":177,"email":189},"michael.motes@utdallas.edu",[191,194],{"name":192,"affiliation":193,"role":181},"John Hart, MD","Callier Clinical Research Center, The University of Texas at Dallas",{"name":183,"affiliation":193,"role":181},[],[],{"nct_id":4,"conditions":198,"biomarkers":200},[199],"Parkinson Disease",[],{"nct_id":4,"found":202,"summary":203,"prompt_version":213},true,{"design":204,"status":205,"heading":206,"summary":207,"follow_up":208,"word_count":209,"commitments":210,"compensation":211,"drugs_mentioned":212},"This study is an interventional trial planning to enroll 20 participants. It compares active transcranial direct current stimulation (tDCS) to a sham (inactive) tDCS treatment.","completed","Transcranial Direct Current Stimulation for Cognitive and Motor Deficits in Parkinson's Disease","This study is testing if transcranial direct current stimulation (tDCS) can help improve verbal retrieval (how easily you can find words), thinking abilities, and movement control in people with Parkinson's disease. Researchers will compare active tDCS to sham tDCS (a non-active version) using a device called Neuroelectrics Starstim tES. They will look at how well participants can retrieve words and other cognitive and motor skills after treatment. You may be able to join if you are 50-90 years old, have Parkinson's disease, and experience difficulty with verbal fluency, as shown by specific neuropsychological tests. The study plans to enroll 20 participants.","Participants will be followed for changes in verbal fluency at 1 week and 2 months after treatment.",101,"Not specified in the trial record.","Not stated in the trial record.",[37],"v2"]