رادار التجارب AI | ||
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حالة التجربة السريرية NCT07097051 لـ ضعف الإدراك الخفيف (MCI) هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
Multi-session Transcranial Alternating Current Stimulation to Improve Dual-task Standing and Brain Activity in Older Adults With Mild Cognitive Impairment المرحلة الثانية ٢٠
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07097051 مصممة لدراسة علاج لـضعف الإدراك الخفيف (MCI). إنها تجربة تدخُّلية من المرحلة الثانية وهي يقبل مشاركين. بدأت في ١٥ ذو القعدة ١٤٤٦ هـ مع خطة لتجنيد ٢٠ مشاركًا. تقودها High Point University، ومن المتوقع اكتمالها بحلول ٢٢ رجب ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٦ صفر ١٤٤٧ هـ.
الملخص
Older adults with Mild Cognitive Impairment (MCI) often show less brain activity in a specific range (8-13 Hz, known as alpha power) compared to healthy older adults. Those with lower alpha activity, especially in the front part of the brain, usually have problems with executive functions like planning and multitasking. Our research has shown that older adults with lower alpha power in these areas also struggle more ...عرض المزيد
وصف مفصل
Older adults with Mild Cognitive Impairment (MCI) exhibit reduced brain alpha power (i.e., activity fluctuations in the 8-13 Hz range) compared to healthy older adults, and older adults who exhibit lower alpha activity in the fronto-central areas tend to have impaired executive function. In addition, our group has demonstrated that older adults who exhibit lower fronto-central alpha power during dual-task standing (i...عرض المزيد
العنوان الرسمي
Multi-session Transcranial Alternating Current Stimulation to Improve Dual-task Standing and Brain Activity in Older Adults With Mild Cognitive Impairment
الحالات الطبية
ضعف الإدراك الخفيف (MCI)معرّفات دراسة أخرى
- IRB-FY2025-70
NCT معرّف
تاريخ البدء (فعلي)
2025-05-13
آخر تحديث مُنشور
2025-07-31
تاريخ الاكتمال (المقدر)
2026-12-31
عدد المشاركين المخطط لهم
٢٠
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الثانية
الحالة
يقبل مشاركين
الكلمات الرئيسية
brain stimulation
balance
cognition
executive function
balance
cognition
executive function
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
مزدوج
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةreal tACS The investigators will administer the transcranial alternating current stimulation (tACS) intervention individually tailored to peak alpha power to the participants. This intervention will utilize 8 electrodes; electrode placement and current parameters for each electrode have been optimized using a standard brain to generate an average electric field of 0.25 V/m. To ensure adherence to current safety recommendations...عرض المزيد | التحفيز بالتيار المتردد عبر الجمجمة الحقيقي (tACS) Those who randomized into real tACS arm will receive ten-session of individually tailored tACS targeting peak alpha power for 20-minutes |
مقارن بالدواء الوهميsham tACS The investigators will administer the sham tACS intervention to the participants. They will use an active sham in which very low-level alternating currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the session. Stimulation will start and end with a 60 s ramp up/down to maximize comfort and the entire session will last in 22-minutes. | التحفيز بالتيار المتردد عبر الجمجمة الوهمي (tACS) Those who randomized into sham tACS arm will receive ten-session of active sham tACS intervention for 20-minutes |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
EEG alpha-band power | Change of EEG oscillations and frequency coupling at 8-13 Hz | Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment). |
Change of postural sway speed | his metric assesses the ability to control standing posture | Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment). |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change of executive function score | This metric reflects measures of executive function scores based on individual neuropsychological test of Trail-making Test B completion time | Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment). |
Change of dual-task gait speed | This metric (m/s) assesses the ability to walk and perform a cognitive task at the same time and predicts cognitive decline and the development of dementia. | Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment). |
Timed Up and Go Test completion time | This test assesses time to complete standing from a chair, walking three meters, turning around a cone and returning to a seated position in the chair. | Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment). |
Short Physical Performance Battery score | This common test assesses physical functioning. The score is ranging from 0 to 12, with higher scores indicating better physical performance. | Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment). |
Montreal Cognitive Assessment (MoCA) | This common test assesses global cognitive function. The Montreal Cognitive Assessment (MoCA) test is scored out of a total of 30 points, with higher scores indicating better cognitive function. | Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment). |
Dual-task Standing Postural Sway Path | This metric assesses the ability to stand and perform a cognitive task at the same time and predicts cognitive decline and the development of dementia. | Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment). |
Serial subtraction test performance | This metric assesses the number of correct response on serial subtraction test while standing | Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment). |
Digit Span total recall | This metric assesses working memory. | Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment). |
WAIS-IV Coding test completion time | This metric assesses sustained attention and motor speed. | Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment). |
Brain networks connectivity changes | Measures of functional brain connectivity based on resting-state functional magnetic resonance imaging. | Baseline and immediate post-intervention assessments |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
كبار السن
العمر الأدنى للدراسة
65 Years
الجنس المؤهل
الكل
- Age 65+
- Who have been diagnosed with cognitive impairment (based in MoCA or TICS and Clinical Dementia Rating: CDR 0.5)
- Ability to stand and walk independently
- Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
- Cut off of MOCA score >18 will be applied
- Able and willing to comply with all study requirements informed consent form was signed
- Understanding of the ICF will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
- Cut off of MOCA score <18 will be applied
- Major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
- Blindness or other disabilities that prevent task performance
- Self-reported history of stroke or neurodegenerative disorders other than MCI.
- Self-reported active cancer for which chemo-/radiation therapy is being received.
- Contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuro-active drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp.
High Point University- جامعة ويك فورست
- Hebrew SeniorLife
الجهة المسؤولة عن الدراسة
Melike Kahya, المحقق الرئيسي, Assistant Professor, High Point University
جهة اتصال مركزية للدراسة
جهة اتصال: Melike Kahya, 3368419632, [email protected]
1 مواقع الدراسة في 1 بلدان
North Carolina
High Point University, High Point, North Carolina, 27262, United States
Melike Kahya, جهة اتصال, 3368419632, [email protected]
يقبل مشاركين