Effects of Transcutaneous Electrical Nerve Stimulation (TENS) to Improve the Cognitive Functions in Older Adults
NCT ID: NCT05408689
Last Updated: 2023-09-22
Study Results
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Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2022-05-23
2023-03-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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T1 TENS
In this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks
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.
Concha TENS
In this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks
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.
Control
In this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
2. Having active implants, such as cochlear implants, pacemaker;
3. Having wounds and diseased skin on the electrode position.
55 Years
85 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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Shamay Ng
Professor
Principal Investigators
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Shamay Ng, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
Locations
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The Hong Kong Polytechnic University
Hong Kong, , Hong Kong
Countries
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References
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Other Identifiers
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2022_TVNS
Identifier Type: -
Identifier Source: org_study_id
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