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Noninvasive Brain Stimulation

Brain Stimulation for Frontotemporal Dementia (GIFTeD Trial)

N/A
Recruiting
Led By Emiliano Santarnecchi, PhD
Research Sponsored by Massachusetts General Hospital
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 up to 6 months
Awards & highlights

Summary

This trial will study whether a noninvasive brain stimulation treatment is safe and effective in patients with frontotemporal dementia.

Who is the study for?
This trial is for adults aged 40-80 with a diagnosis of probable frontotemporal dementia, who have completed at least the 8th grade and do not have intellectual disabilities. Participants must be on stable medications for cognition or behavior for over 30 days and have certain scores on cognitive tests. Exclusions include significant other diseases, psychiatric conditions, brain injuries, metal head implants (except dental), pregnancy, substance abuse within six months, hairstyles that impede electrode contact, and other neurodegenerative disorders.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of transcranial alternating current stimulation (tACS) at a frequency of 40 Hz compared to a sham procedure in improving symptoms of frontotemporal dementia. The noninvasive brain stimulation will be administered daily for six weeks. Cognitive function, gamma EEG activity, and brain metabolism are measured before and after treatment.See study design
What are the potential side effects?
Potential side effects may include discomfort at the electrode sites on the scalp during tACS sessions or mild headaches post-treatment. There's also a low risk of provoked seizures in susceptible individuals; however specific exclusion criteria aim to minimize this.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Attrition (withdrawal) rate
Change in Brain Metabolism measured via FDG-PET
Change in Cognition
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: tACSExperimental Treatment1 Intervention
40 Hz transcranial alternating current stimulation (tACS), 30 daily (Monday-Friday) 1-hour sessions
Group II: Sham tACSPlacebo Group1 Intervention
Sham transcranial alternating current stimulation (tACS), 30 daily (Monday-Friday) 1-hour sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Alternating Current Stimulation (tACS)
2019
N/A
~130

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,608 Total Patients Enrolled
6 Trials studying Frontotemporal Dementia
455 Patients Enrolled for Frontotemporal Dementia
Beth Israel Deaconess Medical CenterLead Sponsor
840 Previous Clinical Trials
13,011,649 Total Patients Enrolled
Alzheimer's Drug Discovery FoundationOTHER
21 Previous Clinical Trials
3,068 Total Patients Enrolled
3 Trials studying Frontotemporal Dementia
137 Patients Enrolled for Frontotemporal Dementia

Media Library

Frontotemporal Dementia Research Study Groups: tACS, Sham tACS
~19 spots leftby Dec 2025
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