Clinical trial · Interventional
Multi-Center Study of Sensory Stimulation to Improve Brain Function
Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)
NCT03556280CI-TRIAL-00053462Overtureactive not recruitingN/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 Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.
Conditions
Conditions (10)
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 Disease | — | UNRESOLVED | — |
| Cognitive Decline | — | UNRESOLVED | — |
| Cognitive Impairment | — | UNRESOLVED | — |
| Cognitive Impairment, Mild | — | UNRESOLVED | — |
| Dementia | — | UNRESOLVED | — |
| Dementia Alzheimers | — | UNRESOLVED | — |
| Dementia, Alzheimer Type | — | UNRESOLVED | — |
| Dementia, Mild | — | UNRESOLVED | — |
| Dementia of Alzheimer Type | — | UNRESOLVED | — |
| Mild Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GammaSense Stimulation System (Active Settings) | Device | — | UNRESOLVED |
| GammaSense Stimulation System (Sham Settings) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- Will use the Active GammaSense Stimulation System.
- interventionNames
- Device: GammaSense Stimulation System (Active Settings)
- type
- SHAM_COMPARATOR
- label
- Control Group
- description
- Will use the Sham GammaSense Stimulation System.
- interventionNames
- Device: GammaSense Stimulation System (Sham Settings)
Primary outcomes (1)
- measure
- Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
- timeFrame
- Quarterly over 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * \>= 55 Years old * MMSE 14-26 * Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD * Participation of a caregiver Exclusion Criteria: * Profound hearing or visual impairment * Seizure Disorder * Use of memantine (Namenda or Namzaric) * Implantable devices (non-MR compatible)
References
Publications (3)
- DERIVEDCarbonell F, Zijdenbos AP, Hempel E, Hajos M, Bedell BJ. A novel method for harmonization of PET image spatial resolution without phantoms. EJNMMI Phys. 2025 Mar 14;12(1):23. doi: 10.1186/s40658-025-00740-9. PMID 40082316
- DERIVEDHajos M, Boasso A, Hempel E, Shpokayte M, Konisky A, Seshagiri CV, Fomenko V, Kwan K, Nicodemus-Johnson J, Hendrix S, Vaughan B, Kern R, Megerian JT, Malchano Z. Safety, tolerability, and efficacy estimate of evoked gamma oscillation in mild to moderate Alzheimer's disease. Front Neurol. 2024 Mar 6;15:1343588. doi: 10.3389/fneur.2024.1343588. eCollection 2024. PMID 38515445
- DERIVEDCimenser A, Hempel E, Travers T, Strozewski N, Martin K, Malchano Z, Hajos M. Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. Front Syst Neurosci. 2021 Sep 24;15:746859. doi: 10.3389/fnsys.2021.746859. eCollection 2021. PMID 34630050