Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment
NCT ID: NCT02155946
Last Updated: 2023-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2014-12-01
2021-03-31
Brief Summary
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Detailed Description
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The proposed study focuses specifically on a groundbreaking combination of mnemonic rehabilitation and non-invasive brain stimulation. The main idea is that brain stimulation can enhance functioning in the specific brain regions/networks, thereby increasing the patients' ability to benefit from memory rehabilitation. This will be a randomized, double-blind study (active vs. fake brain stimulation), that provides multiple treatment session. Outcome will be examined using both laboratory-based and real-world memory testing as well as brain imaging. This first-of-its-kind study has the potential to meaningfully translate more "basic" science findings into neuroanatomically targeted and functionally meaningful treatments for our aging population.
The general purpose of this study is to examine the effects of two types of treatments for memory impairment in those with mild cognitive impairment (MCI). One form of treatment is cognitive rehabilitation, which involves teaching new ways to learn and remember information. The second form of treatment uses a type of electrical brain stimulation called transcranial direct current stimulation (tDCS) to increase activity in certain brain areas that may be involved with memory. We will use brain imaging to see whether these treatments changed how individuals learn and remember information. We will also use cognitive tests and questionnaires to examine whether memory (and related abilities) changed because of treatment.
Values were updated in February 2023 after discovering coding errors in the original database. An exploratory outcome variable (effect of brain volumes) was removed at that time since the electrical field analyses are fundamentally dependent on brain volumes - the EF outcome measure remained but was modified to remove the two sham conditions since, by design, they did not receive any electric field (i.e., sham) and the statistical corrections could not be performed.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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active tDCS + mnemonic strategy training
Group receives active brain stimulation plus memory rehabilitation
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
Active brain stimulation
sham tDCS + mnemonic strategy training
Group receives sham brain stimulation plus memory rehabilitation
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
Sham (placebo)
active tDCS + autobiographical memory recall
Group receives active brain stimulation plus reminiscence training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
Active brain stimulation
sham tDCS + autobiographical memory recall
Group receives sham brain stimulation plus reminiscence training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
Sham (placebo)
Interventions
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Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
Active brain stimulation
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
Sham (placebo)
Eligibility Criteria
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Inclusion Criteria
* No history of severe mental illness;
* No current untreated alcohol or substance abuse/dependence;
* English as native and preferred language;
* MRI-compatible if taking part in fMRI studies
* Able to give informed consent.
\- Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004). Additionally, other potential causes of cognitive deficit ruled out by the referring physician
Exclusion Criteria
* History of severe mental illness
* Current untreated alcohol or substance abuse
* Other conditions may exclude; please discuss with contact
50 Years
88 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Benjamin M. Hampstead, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Locations
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VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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N1534-R
Identifier Type: -
Identifier Source: org_study_id