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Non-invasive Brain Stimulation

Transcranial Electrical Stimulation for Mild Cognitive Impairment

N/A
Recruiting
Research Sponsored by Brain Electrophysiology Laboratory Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at the beginning as baseline, then once weekly over the course of study, and then once on the last day of the study, for a total of up to 6 times over up to 37 days of the study.
Awards & highlights

Study Summary

This trial studies the effects of non-invasive brain stimulation during sleep on memory in people with mild cognitive impairment, with the use of special devices and biomarkers.

Who is the study for?
This trial is for adults aged 40-80 without MCI and those aged 55-85 with Amnestic MCI. It's not suitable for individuals on certain medications, with allergies to lidocaine or silver, history of seizures or ECT, severe insomnia or sleep apnea, severe anxiety or depression, metal in the head, pregnancy, adverse reaction to TMS, brain injury/trauma, significant neurological diseases like Parkinson's or stroke.Check my eligibility
What is being tested?
The study tests if a home-use device called SleepWISP can improve deep sleep and memory in people with mild cognitive impairment using transcranial electrical stimulation (TES). Participants will wear devices that monitor brain activity during sleep and an actigraphy watch by day. Blood samples will also be collected.See study design
What are the potential side effects?
While the device is non-invasive and painless there may be potential side effects such as discomfort at the site of application or skin irritation from prolonged use of the monitoring equipment. The blood draw might cause bruising.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at the beginning as baseline, then once weekly over the course of study, and then once on the last day of the study, for a total of up to 6 times over up to 37 days of the study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at the beginning as baseline, then once weekly over the course of study, and then once on the last day of the study, for a total of up to 6 times over up to 37 days of the study. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Device Usability
Duration of N3 Sleep
Percentage of N3 Sleep
Secondary outcome measures
Beta Amyloid Excretion Blood Sample
Epworth Sleepiness Scale (ESS)
Memory Performance
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep Sleep Enhancement with TESExperimental Treatment1 Intervention
Transcranial Electrical Stimulation, 0.5 Hz sine wave, 0.5 mA, between frontal (frontopolar and inferior lateral frontal) and posterior (mastoid and occipital) electrodes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Electrical Stimulation
2019
Completed Early Phase 1
~20

Find a Location

Who is running the clinical trial?

Wake Forest UniversityOTHER
189 Previous Clinical Trials
164,462 Total Patients Enrolled
Brain Electrophysiology Laboratory CompanyLead Sponsor
3 Previous Clinical Trials
73 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,945 Total Patients Enrolled

Media Library

SleepWISP (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05771844 — N/A
Mild Cognitive Impairment Research Study Groups: Deep Sleep Enhancement with TES
Mild Cognitive Impairment Clinical Trial 2023: SleepWISP Highlights & Side Effects. Trial Name: NCT05771844 — N/A
SleepWISP (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05771844 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being monitored for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this research is currently recruiting - it was first posted on the 8th of February 2023 and recently updated on the 6th of March 2023. This trial requires 118 individuals at two different sites to participate in its data collection process."

Answered by AI

Who is eligible for participation in this medical experiment?

"This clinical trial requires that potential participants have had experience with transcranial electrical stimulation and are between the ages of 40-85. Altogether, 118 people need to be enrolled in this study."

Answered by AI

Is enrollment still open for this research project?

"Affirmative, the clinicaltrials.gov database denotes that this medical trial is presently enrolling participants. Initially posted on February 8th 2023, the study requires 118 patients from 2 separate sites."

Answered by AI

What is the end goal of this clinical experiment?

"The primary outcome of this investigation will be evaluated over a time frame and is referred to as Duration of N3 Sleep, while secondary outcomes encompass the Neuropsychiatric Inventory Questionnaire (NPI-Q), Epworth Sleepiness Scale (ESS) and Beta Amyloid Excretion Blood Sample. To measure these metrics, patients are instructed to use the Sleep WISP system for three sessions within 10 days during Phase I of the study. Furthermore, plasma isolated with anticoagulant must be stored at -80 until Aβ detection via Innotest Immunoassay from Fugirebio."

Answered by AI

Who else is applying?

What site did they apply to?
Wake Forest University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Home Sleep Therapy for Older Adults With MCI
2023. "Home Sleep Therapy for Older Adults With MCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05771844.
~26 spots leftby Sep 2024
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