Diminishing Accelerated Long-term Forgetting in Mild Cognitive Impairment: Study Protocol for a Prospective, Double-blind, Placebo-controlled, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This study is designed as a prospective, double-blind, placebo-controlled, randomized parallel-group study that will be completed at the clinical research facility at St. James' Hospital and at Trinity College Dublin, Ireland. A total of 100 amnestic mild cognitive impairment (aMCI) patients will receive a (real or control) non-invasive transcutaneous electrical stimulation procedure. Patients will be assigned to one of four groups. One group will receive active stimulation, while the three groups will be control groups. One groups will be receive sham stimulation (inactive control), while a second group will receive active stimulation and local anesthesia and a third group will stimulate a different nerve (active control; same sensation different nerve). The investigators will include three control groups to verify that the effect is real and location specific and cannot be associated to a sensation effect. The investigators have opted to use a parallel-group design as it is unclear what the carry-over effect and/or wash-out period will be for stimulation. To eliminate subjective bias, all patients and the investigator testing the endpoint measures will be blinded to the type of intervention. The primary outcome, i.e. memory recall, will be determined by a word association task recorded immediately after stimulation, 7 days after stimulation, and 28 days after stimulation. The secondary outcomes is neurophysiological changes determined by resting state EEG, which will be assessed immediately before and after stimulation in the first session. The investigators will conduct this study as follows: 1. Screening aMCI patients. 2. Randomly assigning aMCI patients to one of the four groups. 3. Administering one session active stimulation (n = 25) or control (n = 25 in each of three control group) stimulation paired with a word-association task; administered by research assistant. 4. Behavioral assessments after each of the three blocks of studying the word associations and neural measures immediately after the last session of Behavioral assessments (T0). 5. Behavioral assessments at seven (T1) and 28 (T2) days after stimulation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• ≥50 years

• Diagnosis of probable aMCI or mild AD

• Montreal Cognitive Assessment between 18-25

• Mini Mental State Examination score \>21

• Stable AChl medication \>3 months

• Adequate visual and auditory acuity

• Capacity to understand and sign informed consent

Locations
Other Locations
Ireland
TCIN
RECRUITING
Dublin
Contact Information
Primary
Sven Vanneste, PhD
sven.vanneste@tcd.ie
+35318968521
Backup
Katherine S Adcock, PhD
adcockk@tcd.ie
+3530864589155
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 100
Treatments
Experimental: Active NITESGON
One electrode each will be placed over the left and right C2 dermatomes. A constant current will be applied during the word association task.
Sham_comparator: Sham NITESGON
For sham NITESGON (inactive control), placement of the electrodes will be identical to active NITESGON. Current intensity (ramp down) will gradually be reduced as soon as NITESGON reaches a current flow of 1.5 mA. The rationale behind this sham procedure is to mimic the transient skin sensation at the beginning of active NITESGON without producing any conditioning effects on the brain.
Active_comparator: Active NITESGON + local anesthesia
For active NITESGON + local anesthesia (active control; local nerve anesthesia group), patients will receive NITESGON, in combination with a topical skin anesthetic (lidocaine/prilocaine cream) to reduce any potential contribution from transcutaneous stimulation of peripheral nerves. A current similar to active NITESGON will be applied.
Active_comparator: Active C5/C6
For the active C5/C6 group (active control; same sensation different nerve), the electrodes will be placed over cervical nerves five and six, to mimic the sensation, but change the location. A current similar to active NITESGON will be applied.
Related Therapeutic Areas
Sponsors
Collaborators: Alzheimer's Association
Leads: University of Dublin, Trinity College

This content was sourced from clinicaltrials.gov