Frontotemporal DementiaGIFTeDNCT04425148
Gamma-Induction in FrontoTemporal Dementia Trial
A study testing Transcranial Alternating Current Stimulation (tACS) in people with Frontotemporal Dementia, run by Massachusetts General Hospital at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Frontotemporal Dementia
- What is being tested?
- Transcranial Alternating Current Stimulation (tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Dec 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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;
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- 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
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or family history of treatment resistant epilepsy, with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of the investigator
- History of head injury resulting in prolonged loss of consciousness
- Any metal in the brain, skull or elsewhere unless approved by the responsible MD
- Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
- Past or current history of major depression, bipolar disorder or psychotic disorders, or any other major psychiatric condition.
- Neurological disorder or intracranial lesion (including an incidental finding on MRI)
- Current history of poorly controlled migraines including chronic medication for migraine prevention
- Any unstable medical condition
- Pregnancy
- Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following:
- The participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other CNS active drugs.
- Substance abuse or dependence within the past six months
- Subjects who, in the investigator's opinion, might not be suitable for the study
- Diseased or damaged skin over the face or scalp
- A hair style or head dress that prevents electrode contact with the scalp (for example: thick braids, hair weave, afro, wig)
Trial locations and contacts
2 sites in 2 countries.
Sara Romanella contact
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lorella Battelli, 617-667-9088, lbattell@bidmc.harvard.edu
Lorella Battelli
Italy1 site, 1 recruiting
- Recruiting
Fondazione Santa Lucia
Roma
Caterina Motta, c.motta@hsantalucia.it
Giacomo Koch, MD
About this study
Official title: Non-invasive Brain Stimulation for Gamma-induction and Cognitive Enhancement in FTD (Gamma-Induction in FrontoTemporal Dementia, GIFTeD)
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.
Read the 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 efficacy of gamma-tACS in patients with behavioral variant (bv)-FTD and semantic variant Primary Progressive Aphasia (svPPA), demonstrating tACS potential mechanisms of action, target engagement, and thus informing the design of larger clinical trials.
Participants will be screened at trial sites for determination of eligibility to enter the study on the basis of diagnostic evaluations, according to current diagnostic criteria for probable bv-FTD and safety assessments.
Baseline assessments will consist of behavioral/cognitive evaluations, blood biomarkers, actigraphy, voice biomarkers, EEG and TMS-EEG and tACS with EEG measures, MRI, FDG-PET imaging (5-8 visits). Once participants have met all inclusion and exclusion criteria, they will be randomly assigned to either 6 weeks of daily tACS sessions or 6 weeks of daily Sham tACS sessions.
Post-intervention visits will include FDG-PET scans, MRI, cognitive testing, tACS with EEG, blood biomarkers and TMS-EEG (5-8 visits). A follow-up visit will occur 3 months after the post-invention visit. This visit will include an EEG registration, cognitive testing and behavioral markers.
- tACS is a way of stimulating the brain externally using weak electric currents.
- Electrodes are placed into a cap that you wear on your head.
- A weak electrical current travels back and forth through the electrodes to your head.
- FDG-PET is a way of taking pictures of your brain using a special dye that is absorbed into your body. In this study, the dye will help us to see the glucose uptake in your brain. The PET scans for this study will be done at Massachusetts General Hospital (MGH).
- TMS is a noninvasive way of stimulating the brain and will be used in this study to measure your brain's plasticity. Brain plasticity is the brain's ability to change and learn through experience. TMS uses a magnetic field to cause changes in the brain activity. The magnetic field is produced by a coil that is held next to your scalp. We will measure how your brain responds to the TMS before and after the tACS treatment.
- EEG is used in routine clinical care to measure the brain's electrical activity. EEG involves placing a cap with electrodes onto your head.
The investigators will enroll a sample of 20 age-matched healthy controls, who will undergo evaluations similar to the bv-FTD baseline assessment except for PET imaging. Healthy subjects will not have the tACS intervention.
- Conditions
- Frontotemporal Dementia
- Being tested
- Transcranial Alternating Current Stimulation (tACS), Sham Transcranial Alternating Current Stimulation (sham tACS)
- Keywords
- FTD
- Medical subject headings
- Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Alternating Current Stimulation (tACS)Device
Also called Non-invasive Brain Stimulation, Neuroelectrics Starstim
tACS is a noninvasive way of stimulating the brain externally using weak electric currents. Electrodes are placed into a cap that you wear on your head. A weak electrical current travels back and forth through the electrodes to your head.
Sham Transcranial Alternating Current Stimulation (sham tACS)Device
Sham (placebo) simulation of transcranial alternating current stimulation without receiving any real stimulation.
| Study group | Role | What they receive |
|---|---|---|
| tACS | Experimental | 40 Hz transcranial alternating current stimulation (tACS), 30 daily (Monday-Friday) 1-hour sessions Receives: Device: Transcranial Alternating Current Stimulation (tACS) |
| Sham tACS | Sham comparator | Sham transcranial alternating current stimulation (tACS), 30 daily (Monday-Friday) 1-hour sessions Receives: Device: Sham Transcranial Alternating Current Stimulation (sham tACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition (withdrawal) rate
The rate of enrolled participants who withdraw from the study will be reported
Measured: up to 6 months
Change in Gamma activity
Changes in oscillatory activity in the EEG gamma band will be evaluated before and after the tACS sessions
Measured: up to 6 months
Change in Cognition
Change in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) score will be reported. The score ranges from 0-85 with the higher score meaning greater cognitive impairment.
Measured: up to 6 months
Change in Cognition
Change in Frontal Assessment Battery (FAB) score will be reported. The scores range from 0-18 with a higher score meaning less cognitive impairment.
Measured: up to 6 months
Change in Brain Metabolism measured via FDG-PET
Change in brain glucose metabolism will be measured via FDG-PET after the daily tACS sessions
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start30 Dec 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal DementiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation
- Responsible party
- Principal investigator, Emiliano Santarnecchi, Massachusetts General Hospital
- Investigators
- Emiliano Santarnecchi, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425148
- Sponsor's protocol ID
- 2021P003553
- Acronym
- GIFTeD
- Status last verified
- Feb 2024
- First submitted
- 1 Jun 2020
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Brain Stimulation for Gamma-induction and Cognitive Enhancement in FTD (Gamma-Induction in FrontoTemporal Dementia, GIFTeD)
- ClinicalTrials.gov ID
- NCT04425148
- Acronym / sponsor ID
- GIFTeD / 2021P003553
- Conditions
- Frontotemporal Dementia
- Keywords
- FTD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 efficacy of gamma-tACS in patients with behavioral variant (bv)-FTD and semantic variant Primary Progressive Aphasia (svPPA), demonstrating tACS potential mechanisms of action, target engagement, and thus informing the design of larger clinical trials.
Participants will be screened at trial sites for determination of eligibility to enter the study on the basis of diagnostic evaluations, according to current diagnostic criteria for probable bv-FTD and safety assessments.
Baseline assessments will consist of behavioral/cognitive evaluations, blood biomarkers, actigraphy, voice biomarkers, EEG and TMS-EEG and tACS with EEG measures, MRI, FDG-PET imaging (5-8 visits). Once participants have met all inclusion and exclusion criteria, they will be randomly assigned to either 6 weeks of daily tACS sessions or 6 weeks of daily Sham tACS sessions.
Post-intervention visits will include FDG-PET scans, MRI, cognitive testing, tACS with EEG, blood biomarkers and TMS-EEG (5-8 visits). A follow-up visit will occur 3 months after the post-invention visit. This visit will include an EEG registration, cognitive testing and behavioral markers.
- tACS is a way of stimulating the brain externally using weak electric currents.
- Electrodes are placed into a cap that you wear on your head.
- A weak electrical current travels back and forth through the electrodes to your head.
- FDG-PET is a way of taking pictures of your brain using a special dye that is absorbed into your body. In this study, the dye will help us to see the glucose uptake in your brain. The PET scans for this study will be done at Massachusetts General Hospital (MGH).
- TMS is a noninvasive way of stimulating the brain and will be used in this study to measure your brain's plasticity. Brain plasticity is the brain's ability to change and learn through experience. TMS uses a magnetic field to cause changes in the brain activity. The magnetic field is produced by a coil that is held next to your scalp. We will measure how your brain responds to the TMS before and after the tACS treatment.
- EEG is used in routine clinical care to measure the brain's electrical activity. EEG involves placing a cap with electrodes onto your head.
The investigators will enroll a sample of 20 age-matched healthy controls, who will undergo evaluations similar to the bv-FTD baseline assessment except for PET imaging. Healthy subjects will not have the tACS intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tACS | Experimental | Device: Transcranial Alternating Current Stimulation (tACS)40 Hz transcranial alternating current stimulation (tACS), 30 daily (Monday-Friday) 1-hour sessions |
| Sham tACS | Sham comparator | Device: Sham Transcranial Alternating Current Stimulation (sham tACS)Sham transcranial alternating current stimulation (tACS), 30 daily (Monday-Friday) 1-hour sessions |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (34 listed)
- 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.
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Alternating Current Stimulation (tACS)Also: Non-invasive Brain Stimulation, Neuroelectrics StarstimtACS is a noninvasive way of stimulating the brain externally using weak electric currents. Electrodes are placed into a cap that you wear on your head. A weak electrical current travels back and forth through the electrodes to your head. | Device | tACS |
| Sham Transcranial Alternating Current Stimulation (sham tACS)Sham (placebo) simulation of transcranial alternating current stimulation without receiving any real stimulation. | Device | Sham tACS |
Primary outcome
Attrition (withdrawal) rate
Time frame: up to 6 months
The rate of enrolled participants who withdraw from the study will be reported
Change in Gamma activity
Time frame: up to 6 months
Changes in oscillatory activity in the EEG gamma band will be evaluated before and after the tACS sessions
Change in Cognition
Time frame: up to 6 months
Change in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) score will be reported. The score ranges from 0-85 with the higher score meaning greater cognitive impairment.
Change in Cognition
Time frame: up to 6 months
Change in Frontal Assessment Battery (FAB) score will be reported. The scores range from 0-18 with a higher score meaning less cognitive impairment.
Change in Brain Metabolism measured via FDG-PET
Time frame: up to 3 months
Change in brain glucose metabolism will be measured via FDG-PET after the daily tACS sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Romanella contact
Emiliano Santarnecchi, PhD principal investigator
Massachusetts General Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Alternating Current Stimulation (tACS) in people with Frontotemporal Dementia, run by Massachusetts General Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emiliano Santarnecchi (617-726-9353, esantarnecchi@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attrition (withdrawal) rate (time frame: up to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.