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

Ali Rezai

Status: Withdrawn

Conditions: Alzheimer Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04440891

1904522298

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups

TMS-Stimulation with X-Torp task

Experimental group

Description:

TMS with VR 1 experimental arm

Treatment:

Device: TMS stimulation with X-Torp task

TMS-Stimulation with MindMotion Go

Experimental group

Description:

TMS with VR 2 experimental arm

Treatment:

Device: TMS-Stimulation with MindMotion Go

TMS-Sham with X-Torp task

Sham Comparator group

Description:

TMS sham control with VR 1

Treatment:

Device: TMS-Sham with X-Torp task

TMS-Sham with MindMotion Go

Sham Comparator group

Description:

TMS sham control with sham VR 2

Treatment:

Device: TMS-Sham with MindMotion Go