Effects of Transcutaneous Electrical Nerve Stimulation (TENS) to Improve the Cognitive Functions in Older Adults

The Hong Kong Polytechnic University

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Device: Concha TENS; Device: T1 TENS; Device: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05408689

2022_TVNS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups, including a placebo group

T1 TENS

Experimental group

Description:

In this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks

Treatment:

Device: T1 TENS

Concha TENS

Experimental group

Description:

In this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks

Treatment:

Device: Concha TENS

Control

Placebo Comparator group

Description:

In this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks

Treatment:

Device: Control