Clinical trial NCT04440891: Application of TMS Coupled With VR for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease
Official title: Application of Transcranial Magnetic Stimulation Coupled With Virtual Reality for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive Performance
timeFrame: 6 months after completion study procedure
Secondary outcomes:
measure: Brain MRI
timeFrame: 6 months after completion of study procedure compared to screening
measure: Memory Performance
timeFrame: 6 months after completion of study procedure compared to screening
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Rockefeller Neuroscience Institute
state: West Virginia
Study officials:
affiliation: Rockefeller Neuroscience Institute
name: Marc Haut, PhD
role: STUDY_CHAIR
affiliation: Rockefeller Neuroscience Institute
name: Victor Finomore, PhD
role: STUDY_DIRECTOR
References: