Transcranial Pulse Stimulation of the Brain

ConditionsMild Dementia Aging Well

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65-84

SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women

Age: 65 to 84 years

English speaking

Physically mobile with no history of balance difficulties or major falls

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Active brain stimulationActive comparator 1 intervention

Group B: Sham brain stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Four weeks

Secondary outcomes

NIH Examiner Total Score

The Total Score from the NIH Examiner will provide coverage of frontal executive functions in a manner that could be completed in a short time frame to limit participant burden. The NIH Examiner was chosen as it 1) Can be completed in \~30 minutes; 2) Is computerized and well standardized with norms from a large national cohort of older adults; 3) Provides both accuracy and response time measures; 4) Emphasizes working memory and executive function domains of relevance to the study which are not fully assessed by the ADAS-cog-plus battery; and 5) Has been the subject of considerable focus and investment by NIA.

Time frame

Four weeks

Other outcomes

Arterial Spin Labeling MRI Cerebral Bloodflow Change

Net change in cerebral blood flow of the targeted Default Mode Network regions after intervention.

Time frame

Four weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov

Apply now