ClinicalTrials.gov lists a trial protocol for hippocampal stimulation in mild cognitive impairment
ClinicalTrials.gov lists a trial protocol for hippocampal stimulation in mild cognitive impairment
On September 2, ClinicalTrials.gov published the NCT07799584 record. The researchers plan to enroll 120 people aged 60–80 with mild cognitive impairment. They will compare active stimulation with sham stimulation while both groups complete the same tai chi program.
Mild cognitive impairment involves noticeable problems with memory or thinking while the person remains independent in daily life. The hippocampus contributes to the formation of memories for events. The trial will compare changes in memory, attention, and measures of brain function after repeated stimulation sessions in participants with this condition.
The method is called tTIS. Scalp electrodes deliver two high-frequency currents at 2000 and 2005 Hz. Where their electric fields overlap, they produce a slower 5 Hz rhythm. Before treatment begins, each participant will undergo MRI, and a computer model based on the scan will determine the electrode placement needed to target the left hippocampus.
In a 2023 Nature Neuroscience paper, the researchers first compared their electric field calculations with measurements taken in a human cadaver. They then used functional MRI, an imaging method that detects changes in brain activity, to observe the hippocampal response in 20 healthy volunteers. In a separate group of 21 young participants, a statistical model estimated that stimulation increased the odds of correctly recalling face and name pairs by 12%.
The researchers will now test whether a repeated course of tTIS provides an additional benefit beyond the same tai chi training in people with early cognitive decline.
The active group will receive 20-minute stimulation sessions three times a week for eight weeks, for a total of 24 sessions. Participants in the sham group will have the same electrodes, schedule, and sensations at the beginning and end of each procedure, but current will be delivered only for 30 seconds during the ramp-up and ramp-down periods. Both groups will complete the same tai chi sessions, including tasks involving attention, memory, and switching between movements. Only the stimulation protocol will differ.
An independent statistician will assign participants to the groups in a 1:1 ratio. Participants, healthcare staff, researchers, and outcome assessors will remain unaware of the stimulation assignment. Before and after the treatment course, the team will assess memory and attention, walking while performing a simultaneous cognitive task, and MRI measures. Some assessments will be repeated at week 24. Comparing changes between the two groups will test the specific contribution of tTIS.
#clinical_trials