RECRUITING

Gamma-Induction in FrontoTemporal Dementia Trial

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-12-30

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04425148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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).

Inclusion Criteria

Exclusion Criteria

* 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

* 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).

Contacts and Locations

Study Contact

Emiliano Santarnecchi

CONTACT

617-726-9353

esantarnecchi@mgh.harvard.edu

Sara Romanella

CONTACT

sromanella@mgh.harvard.edu

Principal Investigator

Emiliano Santarnecchi, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Emiliano Santarnecchi, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-30

Study Completion Date2025-12

Study Record Updates

Study Start Date2020-12-30

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Frontotemporal Dementia