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Device
Transcranial Pulse Stimulation for Dementia
N/A
Recruiting
Led By Joseph Gullett, Ph.D.
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four weeks
Awards & highlights
Study Summary
This trial will use ultrasound to stimulate key brain regions to improve cognitive & neural function in older adults & those with mild dementia.
Who is the study for?
This trial is for English-speaking men and women aged 65-84 who are physically mobile without major falls or balance issues. It includes healthy older adults and those with mild dementia, as determined by specific cognitive tests (TICS and MoCA). Exclusions include severe medical conditions, certain medication use, history of brain infections or neurological disorders, MRI contraindications like metal implants, left-handedness/ambidextrousness due to atypical brain function lateralization.Check my eligibility
What is being tested?
The study examines transcranial pulse stimulation (TPS) using Neurolith technology on the brain. Participants will be randomly assigned to receive either active TPS or a sham (placebo-like) procedure in an effort to improve cognitive functions. The effects will be measured before and after treatment among typically aging adults and patients with mild dementia.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of TPS may include discomfort at the site of stimulation, headache, dizziness or nausea during or after treatment. Since it's non-invasive and uses low-intensity pulses, serious side effects are unlikely but participants will be monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ four weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ADAS-Cog-Plus-EF&FA Battery Total Score
Secondary outcome measures
NIH Examiner Total Score
Other outcome measures
Arterial Spin Labeling MRI Cerebral Bloodflow Change
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active brain stimulationActive Control1 Intervention
These participants will receive focused TPS (pulsed stimulation) of the specified default mode network regions as specified in the detailed study description.
Group II: Sham brain stimulationPlacebo Group1 Intervention
These participants will also receive focused TPS (pulsed stimulation) of the specified default mode network regions as specified in the detailed study description, though the device will be set to "Sham" in a blinded fashion by the biostatistician by placing an air pouch in the device hand piece.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,626 Total Patients Enrolled
Joseph Gullett, Ph.D.Principal InvestigatorUniversity of Florida
1 Previous Clinical Trials
75 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a blood clotting disorder or thrombosis.I cannot walk two blocks without stopping or have trouble balancing.I have not taken corticosteroids in the last six weeks.I have a history of heart issues that could raise my risk of stroke.I do not have neurological issues like Parkinson's, stroke, seizures, or brain injuries.I don't have unstable or chronic conditions like advanced cancer or diabetes.I am between 65 and 84 years old.I can move around easily and haven't had major falls or balance issues.I am an older adult with good memory and thinking skills, as shown by my test scores.I have had a serious brain infection in the past.I am not taking any medication that affects my thinking or has strong anticholinergic effects.
Research Study Groups:
This trial has the following groups:- Group 1: Active brain stimulation
- Group 2: Sham brain stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment of geriatric individuals allowed in this research?
"As outlined in the clinical trial's inclusion criteria, patients must be between 65 and 84 years of age. For those who fall outside this range, there are 21 trials available for young adults aged 18 or younger and 427 studies targeting elderly citizens older than 65."
Answered by AI
Is this study currently enrolling participants?
"Clinicaltrials.gov reveals that this research endeavour is no longer actively recruiting participants. Initially posted on August 1st 2023, the study has been inactive since June 14th of the same year. However, there are still 429 other clinical trials currently looking for volunteers across the nation."
Answered by AI
For whom is this research project suitable?
"This study seeks to recruit approximately 20 patients who are in good health and aged between 65 and 84."
Answered by AI
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