Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions for Aging

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Charlestown, MAAgingActive transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions - Other
Eligibility
60 - 85
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether a non-invasive brain stimulation method can improve cognition in older adults, as well as whether certain individual factors contribute to the effect.

Eligible Conditions
  • Aging

Treatment Effectiveness

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to 25 weeks: assessed during week 1, week 2, week 8,week 9, week 17 and week 25

Week 9
Change in inflammatory responses (C)
Change in inflammatory responses (MCP)
Change in inflammatory responses (MIP)
Change in inflammatory responses (TNF)
Change in inflammatory responses (TREM)
Change in inflammatory responses (aggregated)
Change in inflammatory responses (interleukins)
Week 4
Being a responder as determined by Face-name association memory task (FNAME) change scores
Week 25
Performance on other cognitive composite scores: this includes a composite score of memory, a composite score of executive function and the Preclinical Alzheimer's disease cognitive composite.
Performance on the Face-name association memory task (FNAME)

Trial Safety

Trial Design

4 Treatment Groups

Stimulation preceded by cross-over Sham-Stimulation
1 of 4
Stimulation preceded by cross-over Stimulation-Sham
1 of 4
Sham preceded by cross-over Sham-Stimulation
1 of 4
Sham preceded by cross-over Stimulation-Sham
1 of 4

Experimental Treatment

Non-Treatment Group

140 Total Participants · 4 Treatment Groups

Primary Treatment: Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions · Has Placebo Group · N/A

Stimulation preceded by cross-over Sham-Stimulation
Other
Experimental Group · 1 Intervention: Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions · Intervention Types: Other
Stimulation preceded by cross-over Stimulation-Sham
Other
Experimental Group · 1 Intervention: Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions · Intervention Types: Other
Sham preceded by cross-over Sham-Stimulation
Other
ShamComparator Group · 1 Intervention: Sham transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions · Intervention Types: Other
Sham preceded by cross-over Stimulation-Sham
Other
ShamComparator Group · 1 Intervention: Sham transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 25 weeks: assessed during week 1, week 2, week 8,week 9, week 17 and week 25

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,735 Previous Clinical Trials
31,217,160 Total Patients Enrolled
10 Trials studying Aging
794 Patients Enrolled for Aging
National Institute on Aging (NIA)NIH
1,452 Previous Clinical Trials
4,280,038 Total Patients Enrolled
139 Trials studying Aging
72,702 Patients Enrolled for Aging
Heidi IL Jacobs, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
80 Total Patients Enrolled

Eligibility Criteria

Age 60 - 85 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are allowed to have poor vision as long as it can be corrected with special goggles used during the trial.
You are right-handed.
You scored less than 11 on a test that measures depression in older adults.

Frequently Asked Questions

What are the key goals of this medical study?

"The primary ambition of this scientific endeavour, which is to be assessed over a four week period (cross-over), revolves around the Face-name association memory task. Secondary objectives include evaluating fluctuations in inflammatory responses such as interleukins IL-1β, IL-2, IL-6 and IL-8; tumor necrosis factor alpha (TNFα); macrophage inflammatory protein 1b (MIP1B); monocyte chemoattractant protein 1(MCP1); C1q and C3 complement components. After stability analysis has been conducted with advice from Dr Arnold, specific markers will be selected for" - Anonymous Online Contributor

Unverified Answer

Is participation in this study limited to individuals under forty years of age?

"This research study invites individuals aged between 60 and 85 years old to take part in it." - Anonymous Online Contributor

Unverified Answer

Are there still opportunities to join this experiment?

"As indicated on clinicaltrials.gov, enrollment for this medical study is currently open. The trial was initially launched 24th November 2021 and underwent its last update 25th January 2022." - Anonymous Online Contributor

Unverified Answer

Who is capable of participating in this clinical research?

"This clinical trial is currently inviting applicants aged 60 to 85. The aim is for 140 individuals to join the study." - Anonymous Online Contributor

Unverified Answer

How many participants is this clinical trial hoping to recruit?

"Affirmative, according to the records on clinicaltrials.gov this medical trial is actively recruiting for participants. This research was first made available November 24th 2021 and has been recently updated January 25th 2022; requiring a total of 140 individuals from 1 locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.