Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2016-06-30
2027-11-30
Brief Summary
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Detailed Description
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Transcranial electrical stimulation (TES) is a non-invasive, neurorehabilitation procedure in which a weak electric current is passed between electrodes that are placed on the scalp with the intention of modulating excitability of the underlying brain regions. Because the field of TES is relatively young, rapidly evolving, and primarily focused on cognitive neuroscience with "healthy" individuals, there is a clear need for well-conceptualized and conducted clinical research. The current protocol is intentionally broad with respect to both methodology and patient characteristics in order to tailor potential TES interventions to individual patients or small samples. The current protocol utilizes various forms of TES including transcranial direct current stimulation (tDCS), alternating current stimulation (tACS), and random noise stimulation (tRNS) and sham stimulation in older adults. As this is a cross-over design, some participants may receive active (or "real") TES and/or sham TES conditions.This includes head to head comparisons of the different forms of TES. Additionally, TES could be performed in conjunction with cognitively-based intervention since this may enhance the neuroplastic response of the targeted brain region(s) while at the same time shaping/optimizing the pathways that are engaged by cognitively-based interventions. This broad approach is important since etiological differences in cognitive impairment may necessitate distinct interventions.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active TES
Participants will receive "real" tES (tDCS, tACS, tRNS) in which they receive up to 4 milliamps (mA) of stimulation per electrode for up to 40 minutes for up to 260 sessions. As this may be a cross-over design, some participants may receive active and sham conditions.
Active tDCS
Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.
Active tACS
Participants will receive active transcranial alternating current stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Active tRNS
Participants will receive active transcranial random noise stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Sham TES
Participants undergoing this condition will have the exact same procedures as the active group, with the exception that they will receive only sham stimulation for up to 260 sessions.
Sham tDCS
Participants will receive sham tDCS for up to 260 sessions
Sham tACS
Participants will receive sham transcranial alternating current stimulation for up to 260 sessions
Sham tRNS
Participants will receive sham transcranial random noise stimulation for up to 260 sessions
Cognitively based intervention
Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation.
Cognitively based intervention
Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation for up to 260 sessions
Active TES + Cognitively based intervention
This condition combines active TES and cognitively based interventions for some or all of the study sessions
Active tDCS
Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.
Cognitively based intervention
Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation for up to 260 sessions
Active tACS
Participants will receive active transcranial alternating current stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Active tRNS
Participants will receive active transcranial random noise stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Sham TES + Cognitively based intervention
This condition combines sham TES and cognitively based interventions for some or all of the study sessions
Sham tDCS
Participants will receive sham tDCS for up to 260 sessions
Cognitively based intervention
Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation for up to 260 sessions
Sham tACS
Participants will receive sham transcranial alternating current stimulation for up to 260 sessions
Sham tRNS
Participants will receive sham transcranial random noise stimulation for up to 260 sessions
Active TES, Sham TES, Cognitively based interventions
This condition combines active and sham TES with cognitively based interventions using a cross-over design
Active tDCS
Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.
Sham tDCS
Participants will receive sham tDCS for up to 260 sessions
Cognitively based intervention
Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation for up to 260 sessions
Active tACS
Participants will receive active transcranial alternating current stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Sham tACS
Participants will receive sham transcranial alternating current stimulation for up to 260 sessions
Active tRNS
Participants will receive active transcranial random noise stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Sham tRNS
Participants will receive sham transcranial random noise stimulation for up to 260 sessions
Active and Sham TES
Participants will receive active and sham TES
Active tDCS
Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.
Sham tDCS
Participants will receive sham tDCS for up to 260 sessions
Active tACS
Participants will receive active transcranial alternating current stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Sham tACS
Participants will receive sham transcranial alternating current stimulation for up to 260 sessions
Active tRNS
Participants will receive active transcranial random noise stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Sham tRNS
Participants will receive sham transcranial random noise stimulation for up to 260 sessions
Interventions
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Active tDCS
Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.
Sham tDCS
Participants will receive sham tDCS for up to 260 sessions
Cognitively based intervention
Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation for up to 260 sessions
Active tACS
Participants will receive active transcranial alternating current stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Sham tACS
Participants will receive sham transcranial alternating current stimulation for up to 260 sessions
Active tRNS
Participants will receive active transcranial random noise stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Sham tRNS
Participants will receive sham transcranial random noise stimulation for up to 260 sessions
Eligibility Criteria
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Inclusion Criteria
2. Participants will be age 50 or older
Exclusion Criteria
2. Sensory or motor impairments that limit the ability to take part in the study
3. Current alcohol or drug abuse/dependence
4. Those who are currently pregnant or may become pregnant during the duration of the study (if there is a question of pregnancy, pregnancy tests will be available for participants at no charge)
Those who are being evaluated for TES methodology will also be excluded for 1) metallic or electronic implant 2) skull plates or other cranial implants that affect TES
50 Years
ALL
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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Benjamin Hampstead, PhD
Investigator
Principal Investigators
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Benjamin M Hampstead, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan - Department of Psychiatry
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00111090
Identifier Type: -
Identifier Source: org_study_id
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