NCT04440891

Application of TMS Coupled With VR for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease

Application of Transcranial Magnetic Stimulation Coupled With Virtual Reality for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ali Rezai · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized sham control study to evaluate how repetitive Transcranial Magnetic Stimulation (rTMS), interactive cognitive training, or the combination of rTMS and cognitive training reduce the cognitive decline of patients diagnosed with Alzheimer's disease

Detailed description

Participants may be assigned to one of four experimental arms (1-TMS-Stimulation with X-Torp task, 2-TMS-Stimulation with MindMotion Go, 3-TMS-Sham with X-Torp task, 4-TMS-Sham with MindMotion Go.) The study will be conducted in two phases. During Phase 1, participants will be randomized between experimental conditions 1 and 4. Data will be analyzed upon completion of Phase1 and Phase 2 will commence only if there is efficacy in the TMS arm. During Phase2, participants will be randomized to arms 2 and 3.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	TMS stimulation with X-Torp task	TMS-Stimulation with X-Torp task
DEVICE	TMS-Stimulation with MindMotion Go	TMS-Stimulation with MindMotion Go
DEVICE	TMS-Sham with X-Torp task	TMS-Sham with X-Torp task
DEVICE	TMS-Sham with MindMotion Go	TMS-Sham with MindMotion Go

Timeline

• Start date: 2019-10-03
• Primary completion: 2021-11-02
• Completion: 2021-11-02
• First posted: 2020-06-22
• Last updated: 2023-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study