Non-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorHebrew SeniorLife

About this trial

This project aims to examine the efficacy of remote, caregiver-led tES/brain stimulation intervention targeted to improve memory, mobility, and executive functioning among older adults with mild cognitive impairment or mild dementia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

willing and capable to give informed consent for the participation in the study after it has been thoroughly explained

able and willing to comply with all study requirements

an informed consent form was signed

able to read, write, and communicate in English

Disqualifiers

major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis

blindness or other disabilities that prevent task performance

contraindications to tES, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, etc.)

the presence of any active dermatological condition, such as eczema, on the scalp a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active)

    Device

    Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator to the left angular gyrus and prefrontal cortex.

  • Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham)

    Device

    A sham transcranial electrical stimulation (tES) will be administered to the participant in their home by their caregiver administrator to the left angular gyrus and prefrontal cortex. It will physically mimic active stimulation.

  • Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham)

    Device

    Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator. Active tACS to the left angular gyrus and sham tDCS to the prefrontal cortex.

  • Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (active)

    Device

    Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator. Sham tACS to the left angular gyrus and active tDCS to the prefrontal cortex.

Treatment groups

144 Participants
are divided into 4 treatment groups
Group A: tACS(AG) + tDCS(PFC) combo activeExperimental treatment 1 intervention
Group B: tACS(AG) active + tDCS(PFC) shamActive comparator 1 intervention
Group C: tACS(AG) sham + tDCS(PFC) activeActive comparator 1 intervention
Group D: tACS(AG) sham + tDCS(PFC) shamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall

This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time. Total recall is measured by the total number of words out of 15 the participant is able to recall. Scores range from 0 to 15.

Time frame
baseline, immediate post-intervention, 3 month follow up , 6 month follow up
2

Change in Dual Task Cost to Gait

This measure is captured by Mobility Lab™ (APDM Inc) software while the participant is walking with sensors at a) normal speed (speed for single task) and b) walking while counting backwards by 3's or 1's (speed dual task). The formula for cost of the dual task to gait is: (speedsingletask-speeddualtask)/speedsingletask)\*100). Range for dual task cost is as follows: High Risk for falls \> 0.2, Moderate Risk for falls \<= 0.2, Low Risk \< 0.1.

Time frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up

Secondary outcomes

1

Change in Functional Activity Questionnaire

This is a 10-item scale to measure functional status via independent activities of daily living. Each item is a functional activity, and the caregiver/informant rates the participant's ability using the following scoring system: * Dependent = 3 * Requires assistance = 2 * Has difficulty but does by self = 1 * Normal = 0 * Never did \[the activity\] but could do now = 0 * Never did and would have difficulty now = 1 The scores are summed (range 0-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. This test will be used to track functional status over the course of the intervention and follow-up.

Time frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
2

Change in Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores

The Montreal Cognitive Assessment (MoCA) is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains. The total possible score is 30 points; a score of 26 or above is considered normal. Severity of impairment can be determined with the following scores: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment. The maximum total score is 30 and the minimum total score is 0 points. The memory and executive subscales are each on a range of 0 to 5 points.

Time frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
3

Average E-field normal component (En) for left angular gyrus and prefrontal cortex

From magnetic resonance imaging, an E-field normal component value will be computer for each brain voxel. From those measurements an average En value will be computed in the anatomically-defined left AG (i.e., Brodmann areas 39/40), and separately the left PFC (i.e., Brodmann areas 39/40). This outcome of average En will provide information on the amount of current each participant receives during the intervention in the targeted areas.

Time frame
immediate post-intervention
4

Change in Adjusted Trail Making Test performance

The Trail Making Test (TMT) is a test of visual attention and task switching, which consists of two parts (A \& B). It is scored by timing how long it takes to complete each part of the test, separately. The maximum time allowed for part A or part B is 300 seconds. Age and education adjusted norms are available to determine standard scores. The Adjusted performance is calculated by subtracting the time it takes to complete part A (in seconds) from the time it takes (in seconds) to complete part B. This is a measure of executive functioning and also has age and education adjusted norms.

Time frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up

Other outcomes

Sponsors and contacts

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

Hebrew SeniorLife

Lead sponsor

BrightFocus Foundation

Collaborator

National Institute on Aging (NIA)

Collaborator