Clinical trial NCT05408689: Effects of Transcutaneous Electrical Nerve Stimulation (TENS) to Improve the Cognitive Functions in Older Adults
Official title: A Randomized Controlled Clinical Trial of Transcutaneous Electrical Nerve Stimulation to Improve the Cognitive Functions in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Cognitive function
Transcutaneous electrical nerve stimulation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 90
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent evidence has shown that transcutaneous electrical nerve stimulation (TENS) was effective in improving the cognitive function in healthy adult and people with dementia. However, lacking of evidence investigated the effect of TENS in improving the cognitive function and reversing the occurrence of dementia during the period of mild cognitive impairment (MCI), which is the crucial period to prevent the significant loss of cognition function. Therefore, the main objective of this study is to investigate the optimal TENS treatment protocol in improving the cognitive function in older adults with MCI.

Detailed description: This study aims to investigate the effectiveness of 3 intervention protocols (1) In the T1 TENS group, the subject will receive TENS on T1 spine. (2) In the vagus nerve TENS group, the subject will receive TENS on the concha of left outer ear. (3) In the sham stimulation group, the subject will receive sham stimulation on the T1 spine, in improving the cognitive function in older adults with MCI.

Eligibility criteria: Inclusion Criteria:

Should fulfil the diagnosis criteria of MCI (Albert et al., 2011):

1. Concern regarding a change in cognition
2. Impairment in one or more cognitive domains
3. Preservation of independence in functional abilities
4. no signs of dementia were to be present and confirmed by the medical staff and medical records.

Exclusion Criteria:

1. If their medical records reported a history of either psychiatric disorder, alcoholism, cerebral trauma, cerebrovascular disease, hydrocephalus, neoplasm, epilepsy, disturbances of consciousness, insulin-dependent diabetes mellitus or focal brain disorders;
2. Having active implants, such as cochlear implants, pacemaker;
3. Having wounds and diseased skin on the electrode position.

Primary outcomes:
measure: Montreal cognitive assessment (MoCA)
timeFrame: Baseline (0 week)
measure: Montreal cognitive assessment (MoCA)
timeFrame: Mid-intervention (5 week)
measure: Montreal cognitive assessment (MoCA)
timeFrame: Post-intervention (10 week)
measure: Montreal cognitive assessment (MoCA)
timeFrame: 1 month follow-up (14 week)
measure: Digit Span Test
timeFrame: Baseline (0 week)
measure: Digit Span Test
timeFrame: Mid-intervention (5 week)
measure: Digit Span Test
timeFrame: Post-intervention (10 week)
measure: Digit Span Test
timeFrame: 1 month follow-up (14 week)
measure: Visual Memory Span Test
timeFrame: Baseline (0 week)
measure: Visual Memory Span Test
timeFrame: Mid-intervention (5 week)
measure: Visual Memory Span Test
timeFrame: Post-intervention (10 week)
measure: Visual Memory Span Test
timeFrame: 1 month follow-up (14 week)
measure: Stroop Color and Word Test
timeFrame: Baseline (0 week)
measure: Stroop Color and Word Test
timeFrame: Mid-intervention (5 week)
measure: Stroop Color and Word Test
timeFrame: Post-intervention (10 week)
measure: Stroop Color and Word Test
timeFrame: 1 month follow-up (14 week)
measure: Face Recognition Test
timeFrame: Baseline (0 week)
measure: Face Recognition Test
timeFrame: Mid-intervention (5 week)
measure: Face Recognition Test
timeFrame: Post-intervention (10 week)
measure: Face Recognition Test
timeFrame: 1 month follow-up (14 week)
measure: Picture Recognition Test
timeFrame: Baseline (0 week)
measure: Picture Recognition Test
timeFrame: Mid-intervention (5 week)
measure: Picture Recognition Test
timeFrame: Post-intervention (10 week)
measure: Picture Recognition Test
timeFrame: 1 month follow-up (14 week)
measure: Berg Balance Scale (BBS)
timeFrame: Baseline (0 week)
measure: Berg Balance Scale (BBS)
timeFrame: Mid-intervention (5 week)
measure: Berg Balance Scale (BBS)
timeFrame: Post-intervention (10 week)
measure: Berg Balance Scale (BBS)
timeFrame: 1 month follow-up (14 week)
measure: 10 Meter Walking Test (10MWT)
timeFrame: Baseline (0 week)
measure: 10 Meter Walking Test (10MWT)
timeFrame: Mid-intervention (5 week)
measure: 10 Meter Walking Test (10MWT)
timeFrame: Post-intervention (10 week)
measure: 10 Meter Walking Test (10MWT)
timeFrame: 1 month follow-up (14 week)
measure: 6 Minutes Walking Test (6MWT)
timeFrame: Baseline (0 week)
measure: 6 Minutes Walking Test (6MWT)
timeFrame: Mid-intervention (5 week)
measure: 6 Minutes Walking Test (6MWT)
timeFrame: Post-intervention (10 week)
measure: 6 Minutes Walking Test (6MWT)
timeFrame: 1 month follow-up (14 week)
measure: Time Up and Go Test (TUG)
timeFrame: Baseline (0 week)
measure: Time Up and Go Test (TUG)
timeFrame: Mid-intervention (5 week)
measure: Time Up and Go Test (TUG)
timeFrame: Post-intervention (10 week)
measure: Time Up and Go Test (TUG)
timeFrame: 1 month follow-up (14 week)
measure: Community Integration Measure
timeFrame: Baseline (0 week)
measure: Community Integration Measure
timeFrame: Mid-intervention (5 week)
measure: Community Integration Measure
timeFrame: Post-intervention (10 week)
measure: Community Integration Measure
timeFrame: 1 month follow-up (14 week)
measure: Limit of Stability (LOS)-Reaction Time
timeFrame: Baseline (0 week)
measure: Limit of Stability (LOS)-Reaction Time
timeFrame: Mid-intervention (5 week)
measure: Limit of Stability (LOS)-Reaction Time
timeFrame: Post-intervention (10 week)
measure: Limit of Stability (LOS)-Reaction Time
timeFrame: 1 month follow-up (14 week)
measure: Limit of Stability (LOS)-Movement Velocity
timeFrame: Baseline (0 week)
measure: Limit of Stability (LOS)-Movement Velocity
timeFrame: Mid-intervention (5 week)
measure: Limit of Stability (LOS)-Movement Velocity
timeFrame: Post-intervention (10 week)
measure: Limit of Stability (LOS)-Movement Velocity
timeFrame: 1 month follow-up (14 week)
measure: Limit of Stability (LOS)-Endpoint Excursion
timeFrame: Baseline (0 week)
measure: Limit of Stability (LOS)-Endpoint Excursion
timeFrame: Mid-intervention (5 week)
measure: Limit of Stability (LOS)-Endpoint Excursion
timeFrame: Post-intervention (10 week)
measure: Limit of Stability (LOS)-Endpoint Excursion
timeFrame: 1 month follow-up (14 week)
measure: Limit of Stability (LOS)-Maximum Excursion
timeFrame: Baseline (0 week)
measure: Limit of Stability (LOS)-Maximum Excursion
timeFrame: Mid-intervention (5 week)
measure: Limit of Stability (LOS)-Maximum Excursion
timeFrame: Post-intervention (10 week)
measure: Limit of Stability (LOS)-Maximum Excursion
timeFrame: 1 month follow-up (14 week)
measure: Limit of Stability (LOS)-Directional Control
timeFrame: Baseline (0 week)
measure: Limit of Stability (LOS)-Directional Control
timeFrame: Mid-intervention (5 week)
measure: Limit of Stability (LOS)-Directional Control
timeFrame: Post-intervention (10 week)
measure: Limit of Stability (LOS)-Directional Control
timeFrame: 1 month follow-up (14 week)
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Shamay Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
citation: Alzheimer's Association. 2015 Alzheimer's disease facts and figures. Alzheimers Dement. 2015 Mar;11(3):332-84. doi: 10.1016/j.jalz.2015.02.003.
citation: Beste C, Steenbergen L, Sellaro R, Grigoriadou S, Zhang R, Chmielewski W, Stock AK, Colzato L. Effects of Concomitant Stimulation of the GABAergic and Norepinephrine System on Inhibitory Control - A Study Using Transcutaneous Vagus Nerve Stimulation. Brain Stimul. 2016 Nov-Dec;9(6):811-818. doi: 10.1016/j.brs.2016.07.004. Epub 2016 Jul 19.
citation: Burger AM, Verkuil B, Van Diest I, Van der Does W, Thayer JF, Brosschot JF. The effects of transcutaneous vagus nerve stimulation on conditioned fear extinction in humans. Neurobiol Learn Mem. 2016 Jul;132:49-56. doi: 10.1016/j.nlm.2016.05.007. Epub 2016 May 21.
citation: Elwood RW. The Wechsler Memory Scale-Revised: psychometric characteristics and clinical application. Neuropsychol Rev. 1991 Jun;2(2):179-201. doi: 10.1007/BF01109053.
citation: Gates NJ, Rutjes AW, Di Nisio M, Karim S, Chong LY, March E, Martinez G, Vernooij RW. Computerised cognitive training for 12 or more weeks for maintaining cognitive function in cognitively healthy people in late life. Cochrane Database Syst Rev. 2020 Feb 27;2(2):CD012277. doi: 10.1002/14651858.CD012277.pub3.
citation: Hein E, Nowak M, Kiess O, Biermann T, Bayerlein K, Kornhuber J, Kraus T. Auricular transcutaneous electrical nerve stimulation in depressed patients: a randomized controlled pilot study. J Neural Transm (Vienna). 2013 May;120(5):821-7. doi: 10.1007/s00702-012-0908-6. Epub 2012 Nov 2.
citation: Hiengkaew V, Jitaree K, Chaiyawat P. Minimal detectable changes of the Berg Balance Scale, Fugl-Meyer Assessment Scale, Timed "Up & Go" Test, gait speeds, and 2-minute walk test in individuals with chronic stroke with different degrees of ankle plantarflexor tone. Arch Phys Med Rehabil. 2012 Jul;93(7):1201-8. doi: 10.1016/j.apmr.2012.01.014. Epub 2012 Apr 12.
citation: Holbein-Jenny MA, Billek-Sawhney B, Beckman E, Smith T. Balance in personal care home residents: a comparison of the Berg Balance Scale, the Multi-Directional Reach Test, and the Activities-Specific Balance Confidence Scale. J Geriatr Phys Ther. 2005;28(2):48-53.
citation: Jansen WJ, Ossenkoppele R, Knol DL, Tijms BM, Scheltens P, Verhey FR, Visser PJ; Amyloid Biomarker Study Group; Aalten P, Aarsland D, Alcolea D, Alexander M, Almdahl IS, Arnold SE, Baldeiras I, Barthel H, van Berckel BN, Bibeau K, Blennow K, Brooks DJ, van Buchem MA, Camus V, Cavedo E, Chen K, Chetelat G, Cohen AD, Drzezga A, Engelborghs S, Fagan AM, Fladby T, Fleisher AS, van der Flier WM, Ford L, Forster S, Fortea J, Foskett N, Frederiksen KS, Freund-Levi Y, Frisoni GB, Froelich L, Gabryelewicz T, Gill KD, Gkatzima O, Gomez-Tortosa E, Gordon MF, Grimmer T, Hampel H, Hausner L, Hellwig S, Herukka SK, Hildebrandt H, Ishihara L, Ivanoiu A, Jagust WJ, Johannsen P, Kandimalla R, Kapaki E, Klimkowicz-Mrowiec A, Klunk WE, Kohler S, Koglin N, Kornhuber J, Kramberger MG, Van Laere K, Landau SM, Lee DY, de Leon M, Lisetti V, Lleo A, Madsen K, Maier W, Marcusson J, Mattsson N, de Mendonca A, Meulenbroek O, Meyer PT, Mintun MA, Mok V, Molinuevo JL, Mollergard HM, Morris JC, Mroczko B, Van der Mussele S, Na DL, Newberg A, Nordberg A, Nordlund A, Novak GP, Paraskevas GP, Parnetti L, Perera G, Peters O, Popp J, Prabhakar S, Rabinovici GD, Ramakers IH, Rami L, Resende de Oliveira C, Rinne JO, Rodrigue KM, Rodriguez-Rodriguez E, Roe CM, Rot U, Rowe CC, Ruther E, Sabri O, Sanchez-Juan P, Santana I, Sarazin M, Schroder J, Schutte C, Seo SW, Soetewey F, Soininen H, Spiru L, Struyfs H, Teunissen CE, Tsolaki M, Vandenberghe R, Verbeek MM, Villemagne VL, Vos SJ, van Waalwijk van Doorn LJ, Waldemar G, Wallin A, Wallin AK, Wiltfang J, Wolk DA, Zboch M, Zetterberg H. Prevalence of cerebral amyloid pathology in persons without dementia: a meta-analysis. JAMA. 2015 May 19;313(19):1924-38. doi: 10.1001/jama.2015.4668.
citation: Jonsdottir S, Bouma A, Sergeant JA, Scherder EJ. Effects of transcutaneous electrical nerve stimulation (TENS) on cognition, behavior, and the rest-activity rhythm in children with attention deficit hyperactivity disorder, combined type. Neurorehabil Neural Repair. 2004 Dec;18(4):212-21. doi: 10.1177/1545968304270759.
citation: Langa KM, Levine DA. The diagnosis and management of mild cognitive impairment: a clinical review. JAMA. 2014 Dec 17;312(23):2551-61. doi: 10.1001/jama.2014.13806.
citation: Liu TW, Ng SS, Ng GY. Translation and initial validation of the Chinese (Cantonese) version of community integration measure for use in patients with chronic stroke. Biomed Res Int. 2014;2014:623836. doi: 10.1155/2014/623836. Epub 2014 Jun 4.
citation: Luijpen MW, Swaab DF, Sergeant JA, van Dijk KR, Scherder EJ. Effects of transcutaneous electrical nerve stimulation (TENS) on memory in elderly with mild cognitive impairment. Behav Brain Res. 2005 Mar 30;158(2):349-57. doi: 10.1016/j.bbr.2004.09.017.
citation: Prince, M. J., Wimo, A., Guerchet, M. M., Ali, G. C., Wu, Y. T., & Prina, M. (2015). World Alzheimer Report 2015-The Global Impact of Dementia: An analysis of prevalence, incidence, cost and trends.
citation: Scherder EJ, Bouma A. Effects of transcutaneous electrical nerve stimulation on memory and behavior in Alzheimer's disease may be stage-dependent. Biol Psychiatry. 1999 Mar 15;45(6):743-9. doi: 10.1016/s0006-3223(98)00072-9.
citation: Scherder EJ, Bouma A, Steen L. Influence of transcutaneous electrical nerve stimulation on memory in patients with dementia of the Alzheimer type. J Clin Exp Neuropsychol. 1992 Nov;14(6):951-60. doi: 10.1080/01688639208402546.
citation: Scherder EJ, Bouma A, Steen LM. Effects of "isolated" transcutaneous electrical nerve stimulation on memory and affective behavior in patients with probable Alzheimer's disease. Biol Psychiatry. 1998 Mar 15;43(6):417-24. doi: 10.1016/s0006-3223(97)00208-4.
citation: Sellaro R, de Gelder B, Finisguerra A, Colzato LS. Transcutaneous vagus nerve stimulation (tVNS) enhances recognition of emotions in faces but not bodies. Cortex. 2018 Feb;99:213-223. doi: 10.1016/j.cortex.2017.11.007. Epub 2017 Nov 23.
citation: Sellaro R, van Leusden JW, Tona KD, Verkuil B, Nieuwenhuis S, Colzato LS. Transcutaneous Vagus Nerve Stimulation Enhances Post-error Slowing. J Cogn Neurosci. 2015 Nov;27(11):2126-32. doi: 10.1162/jocn_a_00851. Epub 2015 Jul 30.
citation: Shimada, Hiroyuki, Sangyoon Lee, and Hyuma Makizako.
citation: Shimada H, Makizako H, Doi T, Lee S, Lee S. Conversion and Reversion Rates in Japanese Older People With Mild Cognitive Impairment. J Am Med Dir Assoc. 2017 Sep 1;18(9):808.e1-808.e6. doi: 10.1016/j.jamda.2017.05.017. Epub 2017 Jul 12.
citation: Steenbergen L, Sellaro R, Stock AK, Verkuil B, Beste C, Colzato LS. RETRACTED: Transcutaneous vagus nerve stimulation (tVNS) enhances response selection during action cascading processes. Eur Neuropsychopharmacol. 2015 Jun;25(6):773-8. doi: 10.1016/j.euroneuro.2015.03.015. Epub 2015 Mar 30.
citation: Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128.
citation: Stroop, J. R. (1935). Studies of interference in serial verbal reactions. Journal of experimental psychology, 18(6), 643.
citation: Thomas KR, Edmonds EC, Eppig JS, Wong CG, Weigand AJ, Bangen KJ, Jak AJ, Delano-Wood L, Galasko DR, Salmon DP, Edland SD, Bondi MW; Alzheimer's Disease Neuroimaging Initiative. MCI-to-normal reversion using neuropsychological criteria in the Alzheimer's Disease Neuroimaging Initiative. Alzheimers Dement. 2019 Oct;15(10):1322-1332. doi: 10.1016/j.jalz.2019.06.4948. Epub 2019 Sep 5.
citation: Viveiro LAP, Gomes GCV, Bacha JMR, Carvas Junior N, Kallas ME, Reis M, Jacob Filho W, Pompeu JE. Reliability, Validity, and Ability to Identity Fall Status of the Berg Balance Scale, Balance Evaluation Systems Test (BESTest), Mini-BESTest, and Brief-BESTest in Older Adults Who Live in Nursing Homes. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):E45-E54. doi: 10.1519/JPT.0000000000000215.
citation: de Wall C, Wilson BA, Baddeley AD. The Extended Rivermead Behavioural Memory Test: a measure of everyday memory performance in normal adults. Memory. 1994 Jun;2(2):149-66. doi: 10.1080/09658219408258942.
citation: Wang, R.-Y., Zhou, J.-H., Huang, Y.-C., & Yang, Y.-R. (2018). Reliability of the Chinese version of the Trail Making Test and Stroop Color and Word Test among older adults. International Journal of Gerontology, 12(4), 336-339.
citation: Yeung PY, Wong LL, Chan CC, Leung JL, Yung CY. A validation study of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) in Chinese older adults in Hong Kong. Hong Kong Med J. 2014 Dec;20(6):504-10. doi: 10.12809/hkmj144219. Epub 2014 Aug 15.