Status:
RECRUITING
Gamma-Induction in FrontoTemporal Dementia Trial
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Alzheimer's Drug Discovery Foundation
Conditions:
Frontotemporal Dementia
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief 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 non...
Detailed Description
This is an interventional, multi-site, randomized, double-blind, placebo-controlled study of tACS in patients with FTD. The main aim of this study is to investigate the safety, tolerability and effica...
Eligibility Criteria
Inclusion
- FTD Participants
- 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
Exclusion
- Current or past history of any significant neurodegenerative disorder of the central nervous system other than FTD e.g. Alzheimer's disease, Lewy body dementia, Parkinson's disease, multiple sclerosis, progressive supranuclear palsy, normal pressure hydrocephalus, Huntington's disease, any condition directly or indirectly caused by Transmissible Spongiform Encephalopathy (TSE), Creutzfeldt-Jakob Disease (CJD), variant Creutzfeldt-Jakob Disease (vCJD), or new variant Creutzfeldt-Jakob Disease (nvCJD);
- Current or past history of stroke (cortical stroke), intracranial brain lesions, previous neurosurgery or head trauma that resulted in residual neurologic impairment.
- Non-cortical disease such as confluence white matter changes (including lacunar infarcts \< 1cm) and asymptomatic, subacute, cerebellar infarcts may be included upon review of a medically responsible neurologist.
- Past or current history of major depression, bipolar disorder, psychotic disorders, or any other major psychiatric condition will be evaluated by the study MD.
- Current history of poorly controlled migraines including chronic medication for migraine prevention
- History of seizures with the exception of a single seizure of benign etiology (e.g. febrile seizure) in the judgment of the investigator;
- History of fainting spells of unknown or undetermined etiology that might constitute seizures.
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.).
- Metal implants in the head (except dental), pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt, cochlear implant, unless cleared by the study MD.
- Contraindication for undergoing MRI or receiving TMS or tACS;
- Any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included;
- \>50 mSv of radiation exposure for research within the past year (PET imaging exclusion);
- Substance abuse or dependence within the past six months;
- Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following: The patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination of CNS active drugs;
- All female participants that are pre-menopausal will be required to have a pregnancy test; any participant who is pregnant or breastfeeding will not be enrolled in the study;
- Subjects who, in the investigator's opinion, might not be suitable for the study;
- A hair style or head dress that prevents electrode contact with the scalp or would interfere with the stimulation (for example: thick braids, hair weave, afro, wig).
- Healthy Volunteers
- Inclusion Criteria:
- 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
Key Trial Info
Start Date :
December 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04425148
Start Date
December 30 2020
End Date
December 1 2025
Last Update
September 26 2024
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Fondazione Santa Lucia
Roma, Italy