NCT01168466

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
Last Updated

April 2, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

July 21, 2010

Last Update Submit

March 30, 2018

Conditions

Keywords

Frontotemporal Lobar DegenerationEEG BiofeedbackCerebral oxygenation biofeedbackFrontotemporal DementiaPeak Alpha AmplitudeQuantitative EEG Assessment

Outcome Measures

Primary Outcomes (2)

  • Delis-Kaplan Executive Function System, Behavior Rating Inventory of Executive Function- Adult Version, Integrated Visual and Auditory Continuous Performance Test, Symptom Checklist 90R

    Within two weeks of last session

  • EEG amplitude

    decreased slow wave amplitudes from 1-4hz

    within two weeks of last session

Study Arms (2)

Neurofeedback

NO INTERVENTION

Waitlist control group.

QEEG-based Neurofeedback Training

EXPERIMENTAL

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.

Behavioral: QEEG-based Neurofeedback Training

Interventions

EEG amplitude is measured and visual and auditory rewards are given when amplitude at specific locations is modified to meet preset threshholds.

Also known as: Neurofeedback
QEEG-based Neurofeedback Training

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quietmind Foundation

Lafayette Hill, Pennsylvania, 19444-1800, United States

Location

MeSH Terms

Conditions

DementiaFrontotemporal Lobar DegenerationFrontotemporal Dementia

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Marvin H Berman, Ph.D.

    Quietmind Foundation

    PRINCIPAL INVESTIGATOR
  • Jon Frederick, Ph.D.

    Quietmind Foundation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

July 21, 2010

First Posted

July 23, 2010

Study Start

June 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 2, 2018

Record last verified: 2018-03

Locations