Non-invasive Brain Stimulation for Gamma-induction and Cognitive Enhancement in FTD (Gamma-Induction in FrontoTemporal Dementia, GIFTeD)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is an interventional, sham controlled, double-blind study designed to investigate the safety, tolerability and efficacy of 40 Hz transcranial alternating current stimulation (tACS), a form of noninvasive brain stimulation, delivered for 6 weeks once daily in frontotemporal dementia (FTD) patients. Cognition, gamma EEG activity and brain metabolism via FDG-PET will be measured before and after the tACS intervention.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: t
View:

• Diagnosis of probable Frontotemporal dementia (bvFTD or svPPA)

• Mini Mental State Examination (MMSE) \> 18

• FTLD-specific Clinical Dementia Rating (FTLD-CDR) total score of ≤1

• On stable medications related to cognition or behavior for \>30 days such as acetylcholinesterase inhibitors, memantine, anti-depressants, antipsychotic agents, other mood stabilizers, benzodiazepines;

• Age from 40 to 85 years;

• Minimum of completed 8th grade education

• No history of intellectual disability

• Age: 40-85 years

• Normal healthy volunteer

• Right-handed (assessed by means of the Edinburgh Handedness Questionnaire)

• MMSE \>27

• Minimum of completed 8th grade education

• No history of intellectual disability

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Other Locations
Italy
Fondazione Santa Lucia
RECRUITING
Roma
Contact Information
Primary
Emiliano Santarnecchi
esantarnecchi@mgh.harvard.edu
617-726-9353
Backup
Sara Romanella
sromanella@mgh.harvard.edu
Time Frame
Start Date: 2020-12-30
Estimated Completion Date: 2025-12
Participants
Target number of participants: 70
Treatments
Experimental: tACS
40 Hz transcranial alternating current stimulation (tACS), 30 daily (Monday-Friday) 1-hour sessions
Sham_comparator: Sham tACS
Sham transcranial alternating current stimulation (tACS), 30 daily (Monday-Friday) 1-hour sessions
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: Alzheimer's Drug Discovery Foundation

This content was sourced from clinicaltrials.gov