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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

GIFTeD Trial 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.

GIFTeD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

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

GIFTeD 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,939 Previous Clinical Trials

13,199,335 Total Patients Enrolled

6 Trials studying Frontotemporal Dementia

768 Patients Enrolled for Frontotemporal Dementia

Beth Israel Deaconess Medical CenterLead Sponsor

839 Previous Clinical Trials

13,010,486 Total Patients Enrolled

Alzheimer's Drug Discovery FoundationOTHER

21 Previous Clinical Trials

3,071 Total Patients Enrolled

3 Trials studying Frontotemporal Dementia

137 Patients Enrolled for Frontotemporal Dementia

Media Library

Frontotemporal Dementia Research Study Groups: tACS, Sham tACS

Frequently Asked Questions

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

Do elderly people aged 80 and above qualify as participants in this experiment?

"According to the stated terms of participation, individuals must be a minimum age of 40 and an upper limit of 80."

Answered by AI

How many participants are partaking in this clinical trial?

"Affirmative. Information on clinicaltrials.gov demonstrates that this trial commenced in the last day of 2020 and is still actively recruiting as recently updated on September 29th 2022, aiming to recruit 70 patients from a single site."

Answered by AI

Who does this trial seek to recruit?

"This clinical trial is enrolling up to 70 individuals with semantic dementia who are older than 40 and younger than 80."

Answered by AI

Is enrollment for this experiment ongoing?

"According to the clinicaltrials.gov data, this medical study is currently recruiting participants. It was initial posted on December 30th 2020 and most recently modified on September 29th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gamma-Induction in FrontoTemporal Dementia Trial

Emiliano Santarnecchi 2020. "Gamma-Induction in FrontoTemporal Dementia Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04425148.

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