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Find more clinical trials

Brain Wave Stimulation for Frontotemporal Dementia

Start: December 30, 2020
End: March 2024
Enrollment: 70

What Is This Study About?

Transcranial alternating current stimulation (tACS) is a noninvasive method of applying weak electrical current to the brain using a cap with electrodes worn on the head. This study will test the effects of tACS to improve cognition in people with behavioral variant frontotemporal dementia (bvFTD). Participants will be randomly assigned to receive either the tACS intervention or a sham stimulation, daily for six weeks. In addition, participants will undergo assessments and tests, including a position emission tomography brain scans, so researchers can measure the effects of the stimulation on cognition, brain electrical activity and energy use, and brain plasticity, which is the brain's ability to create new neural connections. The study will also enroll 20 healthy volunteers who will receive the same assessments as the bvFTD participants, but will not receive the tACS intervention.

Do I Qualify To Participate in This Study?

Minimum Age: 40 Years

Maximum Age: 80 Years

Must have:

All Participants:

  • Minimum 8th grade education
  • No history of intellectual disability

Participants With bvFTD:

  • Diagnosis of probable bvFTD
  • Mini-Mental State Examination score of 18 or more
  • FTD-specific Clinical Dementia Rating total score of 1
  • If on medications for cognition or behavior (e.g., acetylcholinesterase inhibitors, memantine, antidepressants, antipsychotic agents, benzodiazepines), must be on same dose for at least four weeks

Healthy Volunteers:

  • Right-handed, based on the Edinburgh Handedness Questionnaire
  • Mini-Mental State Examination score above 27

Must NOT have:

All Participants:

  • History of stroke, intracranial brain lesions, previous brain surgery, or head trauma that resulted neurologic impairment
  • History of seizures (with the exception of a single seizure not caused by a permanent condition), diagnosis of epilepsy, abnormal electroencephalogram, or family history of epilepsy
  • History of major depression, bipolar disorder, psychotic disorders, or any other major psychiatric condition
  • Poorly controlled migraines including taking medication regularly for migraine prevention
  • History of fainting spells of unknown or undetermined cause
  • Any metal in the brain, skull, or elsewhere, excluding dental
  • Any medical devices (e.g., pacemaker, medication pump, nerve stimulator, cochlear implant)
  • Any significant or unstable medical condition (e.g., liver, kidney, hormonal, cardiovascular, gastrointestinal) that may interfere with participation in the study
  • Pregnant or breastfeeding (premenopausal females must have a pregnancy test)
  • Substance abuse or dependence within the past six months
  • Diseased or damaged skin over the face or scalp
  • Hair style or head dress that prevents electrode contact with the scalp or would interfere with the stimulation (e.g., thick braids, hair weave, Afro, wig)

Participants With bvFTD:

  • History of neurological disorder other than bvFTD, e.g., Alzheimer's disease, Lewy body dementia, Parkinson's disease, multiple sclerosis, progressive supranuclear palsy, normal pressure hydrocephalus, Huntington's disease, or any condition caused by transmissible spongiform encephalopathy or Creutzfeldt-Jakob disease
  • Non-cortical brain disease such as white matter changes or asymptomatic cerebellar infarcts
  • Radiation exposure, higher than 50 mSV, used during a research study within the past year

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Study Contact
Julianne Reilly
Andrea Norton

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Massachusetts
Beth Israel Deaconess Medical Center
Boston, MA 02215
Recruiting
Julianne Reilly

Who Sponsors This Study?

Lead: Beth Israel Deaconess Medical Center

Collaborator Sponsor

  • Alzheimer's Drug Discovery Foundation
  • Massachusetts General Hospital

Source: ClinicalTrials.gov ID: NCT04425148

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