Clinical trial · Interventional
Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
Multi-Center Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
NCT03661034CI-TRIAL-00053470unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Etude Study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alzheimer Dementia | — | UNRESOLVED | — |
| Alzheimer Disease | — | UNRESOLVED | — |
| Alzheimer Disease, Early Onset | — | UNRESOLVED | — |
| Alzheimer Disease, Late Onset | — | UNRESOLVED | — |
| Cognitive Decline | — | UNRESOLVED | — |
| Cognitive Impairment | — | UNRESOLVED | — |
| Dementia, Alzheimer Type | — | UNRESOLVED | — |
| Dementia, Mild | — | UNRESOLVED | — |
| Memory Disorders | — | UNRESOLVED | — |
| Memory Disorders, Age Related | — | UNRESOLVED | — |
| Memory Impairment | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GammaSense Stimulation System (non-invasive, non-significant risk) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1, Arm A
- description
- Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk)
- interventionNames
- Device: GammaSense Stimulation System (non-invasive, non-significant risk)
- type
- EXPERIMENTAL
- label
- Cohort 1, Arm B
- description
- Dosing 1 hour session twice per day with GammaSense Stimulation System (non-invasive, non-significant risk)
- interventionNames
- Device: GammaSense Stimulation System (non-invasive, non-significant risk)
- type
- EXPERIMENTAL
- label
- Cohort 2, Arm C
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * \>= 50 Years Old * MMSE 24 - 30 * Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD * Participation of a caregiver / care partner * Amyloid Positive PET Scan Exclusion Criteria: * Profound hearing or visual impairment * Seizure Disorder * Use of memantine (Namenda or Namzaric) * Implantable devices (non-MR compatible)
References
Publications (0)
Data not yet available
No reference posted for this study.