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

NCT05408689 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-09-22

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

T1 TENS

The subjects in Group A will received TENS (Burst mode, 9 pulses per burst, pulse frequency =160Hz, burst frequency=2Hz, intensity was set to trigger visible muscular twitches). Two 2 x 3 cm electrodes was attached on T1 level with 2 cm from the spine. Previous study has shown that it was effective to improve the cognitive function in subjects with Alzheimer's disease.

DEVICE

Concha TENS

The subjects in Group B will received TENS (25Hz, 0.5mA) on the concha of left outer ear. The electrical stimulation was generated by the portable neurostimulator (Nemos®, Cerbomed, Erlangen, Germany) and was delivered by a titanium electrodes positioning on top of a silicon earplug. Previous study has shown that it was effective to improve the Accelerate extinction memory formation and retention in healthy young adults.

DEVICE

Control

The subjects in Group C will receive 30 min sham electrical stimulation on T1 by a placebo-TENS device. The Placebo-TENS was applied by an apparently identical TENS unit. The unit's power indicator light was illuminated, but the unit's electrical circuit had been manually disconnected inside. In order to shape the common mindset, all subjects (except those in the Control group) were informed that they might or might not feel an electrical current, as different stimulation parameters were being applied.

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Shamay Ng, PhD · The Hong Kong Polytechnic University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2023-03-23
Completion
2023-03-23

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05408689 on ClinicalTrials.gov