Gamma-Induction in FrontoTemporal Dementia Trial

NCT04425148 | Recruiting DMC FDA Device

• 1 other identifier: 2021P003553
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 2

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 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.

Conditions

Frontotemporal Dementia

Keywords

FTD

Outcome Measures

Primary Outcomes (5)

• Attrition (withdrawal) rate

  The rate of enrolled participants who withdraw from the study will be reported

  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

  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.

  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.

  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

  up to 3 months

Study Arms (2)

tACS

EXPERIMENTAL

40 Hz transcranial alternating current stimulation (tACS), 30 daily (Monday-Friday) 1-hour sessions

Device: Transcranial Alternating Current Stimulation (tACS)

Sham tACS

SHAM COMPARATOR

Sham transcranial alternating current stimulation (tACS), 30 daily (Monday-Friday) 1-hour sessions

Device: Sham Transcranial Alternating Current Stimulation (sham tACS)

Interventions

Transcranial Alternating Current Stimulation (tACS) DEVICE

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.

Also known as: Non-invasive Brain Stimulation, Neuroelectrics Starstim

tACS

Sham Transcranial Alternating Current Stimulation (sham tACS) DEVICE

Sham (placebo) simulation of transcranial alternating current stimulation without receiving any real stimulation.

Sham tACS

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Substance abuse or dependence within the past six months;
• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Alzheimer's Drug Discovery Foundation: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Fondazione Santa Lucia

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Frontotemporal Dementia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Emiliano Santarnecchi, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emiliano Santarnecchi

CONTACT

617-726-9353; esantarnecchi@mgh.harvard.edu

Sara Romanella

CONTACT

sromanella@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 11, 2020
• Study Start: December 30, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IT (1)