Electroencephalography (EEG) Biofeedback Training to Improve Executive Functioning and Memory in Adults With a Dementing Illness (QMFFTD)
This study has been completed.
Sponsor:
Quietmind Foundation
Information provided by:
Quietmind Foundation
ClinicalTrials.gov Identifier:
NCT01168466
First received: July 21, 2010
Last updated: July 22, 2010
Last verified: July 2010
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Purpose
This study measures whether the symptoms of frontotemporal dementia (FTD) can be successfully treated by (a) biofeedback training to increase brain blood flow, (b) biofeedback to increase the frequency of the brain's dominant brainwave rhythm, and (c) rhythmic stimulation to increase the brain's dominant brainwave frequency.
| Condition | Intervention | Phase |
|---|---|---|
|
Dementia |
Behavioral: HEG Neurofeedback Behavioral: EEG Driven Photic Stimulation Behavioral: Peak Alpha Neurofeedback |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pilot Study of EEG and Cerebral Blood Flow Biofeedback Training in Remediating Cognitive and Behavioral Deficits in Adults With a Dementing Illness. |
Resource links provided by NLM:
Genetics Home Reference related topics:
CHMP2B-related frontotemporal dementia
frontotemporal dementia with parkinsonism-17
GRN-related frontotemporal dementia
inclusion body myopathy with early-onset Paget disease and frontotemporal dementia
MedlinePlus related topics:
Dementia
U.S. FDA Resources
Further study details as provided by Quietmind Foundation:
Primary Outcome Measures:
- Delis-Kaplan Executive Function System, Behavior Rating Inventory of Executive Function- Adult Version, Integrated Visual and Auditory Continuous Performance Test, Symptom Checklist 90R [ Time Frame: Within two weeks of last session ] [ Designated as safety issue: No ]
- EEG amplitude [ Time Frame: within two weeks of last session ] [ Designated as safety issue: No ]decreased slow wave amplitudes from 1-4hz
| Estimated Enrollment: | 42 |
| Study Start Date: | June 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HEG only
This group receives 30 sessions of infrared cerebral blood flow (hemoencephalographic) neurofeedback.
|
Behavioral: HEG Neurofeedback
Detects and displays real time variation in blood flow in outermost 1.5 cm of frontal cerebral cortex.
Other Name: Pendant HEG with Bioexplorer Software
|
|
Experimental: Neurofeedback
A Pendant EEG with Bioexplorer software detects and displays the dominant alpha frequency in real time, rewarding faster frequencies.
|
Behavioral: EEG Driven Photic Stimulation
A Brainmaster EEG monitors the variation brain's dominant frequency in real time, while a Procyon photic stimulation device provides visual stimulation at 1/2 Hz faster, encouraging or "entraining" a faster frequency. In half of the neurofeedback arm, EEG Driven Photic Stimulation will be provided during neurofeedback displaying dominant frequency and rewarding faster frequencies.
Behavioral: Peak Alpha Neurofeedback
A Pendant EEG with Bioexplorer software detects and displays the dominant alpha frequency in real time, rewarding faster frequencies.
|
|
No Intervention: Control
A randomly selected half of participants waits 15 weeks for the other half to complete treatment, and are then reassessed, serving as controls. They then receive the same treatment as the experimental group.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 45 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
FTD Symptoms reported by self or caregiver Significantly abnormal scores on Delis-Kaplan Executive Function System and Behavior Rating Inventory of Executive Function- Adult Version
Exclusion Criteria:
- 45 years of age
- no one with Axis I dx of Bipolar, Psychosis or active Substance Abuse
- no severe Axis II disorders
- symptoms manifesting within the last 5 years and person is still somewhat independent regarding their ADLs.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168466
Locations
| United States, Pennsylvania | |
| Quietmind Foundation | |
| Lafayette Hill, Pennsylvania, United States, 19444-1800 | |
Sponsors and Collaborators
Quietmind Foundation
Investigators
| Principal Investigator: | Marvin H Berman, Ph.D. | Quietmind Foundation |
| Study Director: | Jon Frederick, Ph.D. | Quietmind Foundation |
More Information
No publications provided
| Responsible Party: | Marvin H. Berman PhD, Principal Investigator, Quietmind Founcation |
| ClinicalTrials.gov Identifier: | NCT01168466 History of Changes |
| Other Study ID Numbers: | QMFFTD |
| Study First Received: | July 21, 2010 |
| Last Updated: | July 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Quietmind Foundation:
|
Frontotemporal Lobar Degeneration EEG Biofeedback Cerebral oxygenation biofeedback Peak Alpha Rhythm Biofeedback Frontotemporal Dementia |
Additional relevant MeSH terms:
|
Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 17, 2013