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

Alzheimer Disease Clinical Trial

— TMS_AD  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04440891
• Other study ID #: 1904522298
• Status: Withdrawn
• Phase: N/A
• Start date: October 3, 2019
• Est. completion date: November 2, 2021

Study information

• Verified date: August 2023
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

Male or Female between 50-85 years of age

• Able and willing to give informed consent
• Probable AD consistent with NIA/AA criteria
• Modified Hachinski Ischemia Scale (MHIS) score of <= 4
• Geriatric Depression Scale (GDS) score of <= 6
• Mini Mental State Exam (MMSE) score 18-26. The MMSE adjusted scoring instructions may be followed for screening patients as applicable.

Exclusion Criteria:

• Unstable medical conditions
• Visual impairments
• Mobility limitations
• Cognition-enhancing medication unless on a stable dosage for at least 3 months before the start of the trial.
• History of epilepsy or seizure disorder
• History of psychosis
• Current thoughts of suicidal ideation or self-harm as assessed by the Columbia-Suicide severity rating scale score
• Progressive neurological disorder or focal signs of abnormality on neurological exam as conducted by a neurologist (other than current diagnosis of AD)
• Tinnitus
• Metal implants (excluding dental fillings)
• Possible pregnancy
• Substance use disorder within the past six months
• Have other mental or physical conditions that are inappropriate for study participation at PI's or delegated sub investigator's discretion.
• Intake of one or a combination of the drugs that may due to their significant seizure threshold lowering potential

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction

Intervention

Device:
• TMS stimulation with X-Torp task
TMS-Stimulation with X-Torp task
• TMS-Stimulation with MindMotion Go
TMS-Stimulation with MindMotion Go
• TMS-Sham with X-Torp task
TMS-Sham with X-Torp task
• TMS-Sham with MindMotion Go
TMS-Sham with MindMotion Go

Locations

Country	Name	City	State
United States	West Virginia University Rockefeller Neuroscience Institute	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Ali Rezai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Performance	Change in cognitive task performance over time using the total score on the Mini Mental State Examination (range 0-30)	6 months after completion study procedure
Secondary	Brain MRI	Change in brain structure and function over time	6 months after completion of study procedure compared to screening
Secondary	Memory Performance	Total recall on the California Verbal Learning Test - short form (range 0-36)	6 months after completion of study procedure compared to screening