The Efficacy of Non-invasive Brain Stimulation on Cognitive Functions in Patients With Chronic Obstructive Pulmonary Disease: Double-Blinded Randomised Controlled Trial

Обзор

The goal of this clinical trial is to examine if non-invasive brain stimulation (NIBS) can enhance cognitive function with chronic obstructive pulmonary disease (COPD) population. The main questions it aims to answer are: * What is the possibility effect of using the NIBS on cognitive functions as well as the cardiopulmonary parameters in COPD population? * What is the relation between cognitive function parameters and cardiopulmonary parameters in COPD population who suffer from cognitive impairment (CI)? Researchers will compare NIBS to a sham-NIBS to see if NIBS works to improve cognitive function in COPD population. Participants will: Receive NIBS or a sham-NIBS 5 sessions/week for 3 weeks for 20 min each session. Visit the clinic at the beginning for baseline assessment then after the completion of the 3 weeks to reassess them. Outcome measures for cognitive parameters and pulmonary parameters will be taken pre and post NIBS intervention

Подробное описание

* With over 3.2 million fatalities worldwide, chronic obstructive pulmonary disease (COPD) is considered the third most common cause of mortality and a potentially fatal illness. * Due to anomalies in the lung architecture, COPD is characterised by a variety of respiratory symptoms. * Cognitive impairment (CI) is one of the problems caused by COPD that extends beyond the respiratory system. * The quality of life, treatment compliance, and declines in the condition of COPD patients were all negatively impacted by CI. * As of right now, no intervention has been promised to improve CI in patients with COPD.

Objective:

To find out how well non-invasive brain stimulation (NIBS), a novel technique, affects cognitive performance in COPD patients

Methods:

* Both the participants and the outcome assessor will be in a double-blind RCT. * King Fahad University Hospital will be the source of the entirely voluntary participants. * The IRB of the Imam Abdulrahman bin Faisal institutions accepted the study protocol. * Following an evaluation using the Montreal Cognitive Assessment Test (MoCA), participants will be divided into four groups based on GOLD: mild GOLD 1, moderate GOLD 2, severe GOLD 3, and very severe GOLD 4. * For three weeks, both groups will participate in five NIBS sessions per week. While the control group will receive sham brain stimulation, the experimental group will receive active brain stimulation. * Both groups will undergo the evaluation before and after the treatment sessions. * Primary outcome measurements are battery cognition tests; secondary measures include ABGs, ultrasonography, and cardiopulmonary exercise tests. * Independent t-tests will be applied to evaluate the differences between the two groups. * The study will use a two-way repeated measures Analysis of Variance (ANOVA) to determine the intervention's efficacy. * The association between the improvement of cognitive function and certain factors will be ascertained via the Pearson correlation coefficient. * The significance level will be set at a p-value of less than 0.05.

Significant:

* We hope that the findings of this study will serve as a helpful guide when deciding how to improve CI in patients with COPD and enhance the treatment strategy for this group. * The findings of this study will investigate whether NIBS, which is beneficial in another population, can enhance cognitive function in individuals with COPD.

Вмешательства

• Устройство Non-invasive brain stimulation
  Non-invasive brain stimulation (NIBS) modifies brain activity without surgery using electric currents. - Transcranial alternating current stimulation (tACS) is one type of NIBS that modifies neuronal oscillations in the brain by applying alternating electrical currents to the scalp through electrodes. - This method can enhance motor abilities, improve cognitive functions, and be used in rehabilitation. - It does this by entraining neurones, which synchronise their firing to the applied sinusoida
• Устройство Sham Non-Invasive brain stimulation
  Non-invasive brain stimulation (NIBS) modifies brain activity without surgery using electric currents. - Transcranial alternating current stimulation (tACS) is one type of NIBS that modifies neuronal oscillations in the brain by applying alternating electrical currents to the scalp through electrodes. - This method can enhance motor abilities, improve cognitive functions, and be used in rehabilitation. - It does this by entraining neurones, which synchronise their firing to the applied sinusoida

Первичные конечные точки

• The battery of neurocognitive tests [Срок оценки: At enrolment as baseline assessment and at the end of treatment at 3 weeks]

Вторичные конечные точки (3)

• Cardiopulmonary exercise test (CPET) [Срок оценки: At enrolment as baseline assessment and at the end of treatment at 3 weeks]
• Transcranial Doppler (TCD) ultrasound [Срок оценки: At enrolment as baseline assessment and at the end of treatment at 3 weeks]
• Arterial blood gas analysis (ABGs) [Срок оценки: At enrolment as baseline assessment and at the end of treatment at 3 weeks]

Критерии участия

Критерии включения

• Adult age from eighteen years old and above.
• Patients with confirmed COPD via pulmonary function test (PFT) according to the classifications of GOLD.
• All stages of GOLD will be included
• Stable patients, which means they were not admitted to the hospital in the last 3 months
• Patients with COPD with confirmed cognitive impairment by MoCA test.
• All MoCA stages will be included.

Критерии исключения

• Patients without COPD
• Unstable patients with several admission in the last 3 months
• Patients with COPD but without cognitive impairment.
• COPD patients who suffered from any neurological problems
• COPD patients who are contraindicated for using brain stimulation like psychiatric disorders.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Саудовская Аравия · 1 центр

• Imam Abdulrahman Bin Faisal University — Dammam

Публикации

• Woods AJ, Antal A, Bikson M, Boggio PS, Brunoni AR, Celnik P, Cohen LG, Fregni F, Herrmann CS, Kappenman ES, Knotkova H, Liebetanz D, Miniussi C, Miranda PC, Paulus W, Priori A, Reato D, Stagg C, Wenderoth N, Nitsche MA. A technical guide to tDCS, and related non-invasive brain stimulation tools. Clin Neurophysiol. 2016 Feb;127(2):1031-1048. doi: 10.1016/j.clinph.2015.11.012. Epub 2015 Nov 22. PMID 26652115
• Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan; PMID 27866120
• Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schell PMID 28709880
• Manippa V, Palmisano A, Nitsche MA, Filardi M, Vilella D, Logroscino G, Rivolta D. Cognitive and Neuropathophysiological Outcomes of Gamma-tACS in Dementia: A Systematic Review. Neuropsychol Rev. 2024 Mar;34(1):338-361. doi: 10.1007/s11065-023-09589-0. Epub 2023 Mar 6. PMID 36877327
• Chaieb L, Antal A, Pisoni A, Saiote C, Opitz A, Ambrus GG, Focke N, Paulus W. Safety of 5 kHz tACS. Brain Stimul. 2014 Jan-Feb;7(1):92-6. doi: 10.1016/j.brs.2013.08.004. Epub 2013 Sep 13. PMID 24064065
• Bikson M, Datta A, Elwassif M. Establishing safety limits for transcranial direct current stimulation. Clin Neurophysiol. 2009 Jun;120(6):1033-4. doi: 10.1016/j.clinph.2009.03.018. Epub 2009 Apr 24. No abstract available. PMID 19394269
• Zhou D, Li A, Li X, Zhuang W, Liang Y, Zheng CY, Zheng H, Yuan TF. Effects of 40 Hz transcranial alternating current stimulation (tACS) on cognitive functions of patients with Alzheimer's disease: a randomised, double-blind, sham-controlled clinical trial. J Neurol Neurosurg Psychiatry. 2022 May;93(5):568-570. doi: 10.1136/jnnp-2021-326885. Epub 2021 Nov 11. No abstract available. PMID 34764150
• Antal A, Herrmann CS. Transcranial Alternating Current and Random Noise Stimulation: Possible Mechanisms. Neural Plast. 2016;2016:3616807. doi: 10.1155/2016/3616807. Epub 2016 May 3. PMID 27242932

Идентификаторы

NCT: NCT07332169 · IRB-PGS-2025-03-0600 · IRB-PGS-2025-03-0553

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗