Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT01559220
Brief Summary:
The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS)as a treatment option for patients with cognitive, behavioral, and functional disability of Alzheimer's disease.
Detailed Description:
Open label pilot study
* Expected direct benefit on the modulation of neuronal networks.
* Expected indirect benefit via potential enhancements of memory, executive functions, cognition behavioral control, and functional abilities.
Up to 10 subjects will be implanted with bilateral DBS systems, participants are expected to be on study for about 23 months.
* Develop a multidisciplinary clinical research protocol to evaluate the efficacy of ventral striatum, nucleus accumbens, and internal capsule for the amelioration of disability caused by Alzheimer's Disease.
* Enroll up to 10 patients into an open label study to evaluate the safety and efficacy of DBS for Alzheimer's Disease patients with mild to moderate disability.
* Determine an initial DBS titration and stimulation settings protocol for use in subsequent controlled trials.
* Evaluate the outcomes of this study based on clinical, laboratory, biomarker, imaging, cognitive, behavioral, and functional assessments.
* Determine what domains of cognitive, behavioral and functioning impairment show the greatest response to DBS.
* Examine the potential benefit of stimulation combined with behavioral and rehabilitation interventions in comparison to stimulation alone.
* Evaluate the influence of DBS on physiological and functional changes in cortical and subcortical networks.
Study:
NCT01559220
Study Brief:
Protocol Section:
NCT01559220