Transcranial Pulse Stimulation of the Brain

NCT05910619 | Recruiting FDA Device

• 1 other identifier: IRB202300156
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate transcranial pulse stimulation (TPS) as a method of enhancing cognitive and neural function. The study team will apply this low intensity, magnetically pulse technology to key brain regions in a randomized, sham-controlled trial (RCT). The study will determine the magnitude of changes in cognitive function and brain function and structure between a pre- and post-stimulation among 10 typically-aging older adults and 10 patients with mild dementia.

Conditions

Mild Dementia; Aging Well

Keywords

Mild Dementia; Typical Aging; Transcranial Pulse Stimulation

Outcome Measures

Primary Outcomes (1)

• ADAS-Cog-Plus-EF&FA Battery Total Score

  The ADAS-Cog-Plus total score is touted as the gold standard measure for outcomes measurement following anti-dementia interventions18, allows for reliable longitudinal data collection, and provides coverage of cognitive domains including orientation, memory, language, and praxis.

  Four weeks

Secondary Outcomes (1)

• NIH Examiner Total Score

  Four weeks

Other Outcomes (1)

• Arterial Spin Labeling MRI Cerebral Bloodflow Change

  Four weeks

Study Arms (2)

Active brain stimulation

ACTIVE COMPARATOR

These participants will receive focused TPS (pulsed stimulation) of the specified default mode network regions as specified in the detailed study description.

Device: Neurolith Transcranial Pulse Stimulation Active

Sham brain stimulation

SHAM COMPARATOR

These participants will also receive focused TPS (pulsed stimulation) of the specified default mode network regions as specified in the detailed study description, though the device will be set to "Sham" in a blinded fashion by the biostatistician by placing an air pouch in the device hand piece.

Device: Neurolith Transcranial Pulse Stimulation Sham

Interventions

Neurolith Transcranial Pulse Stimulation Active DEVICE

5hz (200-300 milliseconds) stimulation pulses transcranial pulse stimulation (TPS) will be applied to each of the following five regions twice per session in sequential order with the specified stimulation parameters: left dorsolateral prefrontal cortex and inferior frontal cortex extending to Broca's area (2x800 pulses), right dorsolateral prefrontal cortex and inferior frontal cortex extending to Broca's area (2x800 pulses; ROI volume \~136/164 cms), the left lateral parietal cortex extending to Wernicke's area (2x400 pulses; ROI volume \~122/147 cms), the right lateral parietal cortex extending to Wernicke's area (2x400 pulses; ROI volume \~122/147 cms), and the extended precuneus cortex (2x600 pulses; ROI volume 66/92 cms). With a repetition time of 5hz (0.00333 seconds) per pulse at a total of 6,000 pulses per participant, the duration of stimulation is about 20 minutes, not including transition time between ROI localization.

Active brain stimulation

Neurolith Transcranial Pulse Stimulation Sham DEVICE

The intervention procedure described in the Active condition above will also be repeated in participants randomized to the Sham procedure, with the exception of the insertion of a lens over the device by the interventionist to prevent stimulation from reaching the brain.

Sham brain stimulation

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Men and women
• Age: 65 to 84 years
• English speaking
• Physically mobile with no history of balance difficulties or major falls
• For the typically-aging older adult group, phone screening performance on the TICS must be greater than or equal to 33 points, and cognitive performance of 26 points or greater on the MoCA and a Sum of Boxes score of 0 on the Clinical Dementia Rating scale administered to the participant's informant at the initial visit
• For the Mild dementia group, phone screening performance on the TICS must be between 21 and 32 points, and subsequent cognitive performance of on the MoCA must be \<23 with a CDR Sum of Boxes score between 4.5 and 9.0 as administered to the participants known informant at the initial visit.

You may not qualify if:

• Neurological disorders unrelated to dementia / AD (e.g., Parkinson's disease, stroke, seizures, traumatic brain injury)
• Evidence of greater-than-mild dementia/AD (based on informant CDR Sum of Boxes score greater than 9.0 or MoCA \<10)
• Past opportunistic brain infection
• Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality) or any history of agitation and/or delirium
• Unstable (e.g., cancer other than basal cell skin) and chronic (e.g., diabetes mellitus) medical conditions
• MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI and TPS)
• Physical impairment precluding motor response or lying still for one hour and inability to walk two blocks without stopping or without balance difficulties
• Other history of medical conditions that may increase risk of cerebrovascular events, including prior heart attack, cardiac arrhythmia such as atrial fibrillation
• Hearing or vision deficits that will not allow for reliable standardized cognitive assessment; i.e. colorblindness, inability to hear through headphones (with or without hearing aids), macular degeneration or other significant diseases that cause severe loss of vision. If vision is corrected with lenses to appropriate levels, then participant will be eligible
• Left-handedness and ambidextrousness, as these individuals have a higher percentage rate of atypical functional lateralization for brain functions, which would significantly interfere with interpretability of brain data
• Hemophilia or other blood clotting disorders or thrombosis
• Corticosteroid treatment within the last six weeks before the first treatment

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Study Officials

• Joseph Gullett, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph M Gullett, Ph.D.

CONTACT

352-294-8631; gullettj@phhp.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All parties involved will be blinded to the participant condition with the exception of 1) the interventionist applying the pulsed stimulation to the participant brain, as they will be required to ensure the TPS device is set to sham/active before application of the stimulation, and 2) the biostatistician who will randomize participants with sex-stratification
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 sham-controlled design in which 10 typically-aging older adults and 10 patients with mild AD will be randomized to receive either sham TPS or active TPS

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 20, 2023
• Study Start: February 16, 2024
• Primary Completion: February 16, 2026
• Study Completion (Estimated): July 7, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)