Electroencephalography (EEG) Biofeedback Training to Improve Executive Functioning and Memory in Adults With a Dementing Illness (QMFFTD)

This study has been completed.
Sponsor:
Information provided by:
Quietmind Foundation
ClinicalTrials.gov Identifier:
NCT01168466
First received: July 21, 2010
Last updated: July 22, 2010
Last verified: July 2010
  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:


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 April 17, 2014