Biofeedback for Attention-deficit/Hyperactivity Disorder (ADHD) in adults: A comparison of different treatments: Slow cortical potentials feedback, frontal lobe oxygen consummation feedback and feedback of muscular tension/relaxation

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00006767
• Date of registration: 08/10/2014
• Prospective Registration: No
• Primary sponsor: Eberhard Karls Universität Tübingen
• Public title: Biofeedback for Attention-deficit/Hyperactivity Disorder (ADHD) in adults: A comparison of different treatments: Slow cortical potentials feedback, frontal lobe oxygen consummation feedback and feedback of muscular tension/relaxation
• Scientific title: Biofeedback for Attention-deficit/Hyperactivity Disorder (ADHD) in adults: A comparison of different treatments: Slow cortical potentials feedback, frontal lobe oxygen consummation feedback and feedback of muscular tension/relaxation - Feedback adults ADHD
• Date of first enrolment: 26/02/2011
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00006767
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Beatrix Barth
• Affiliation: Klinik für Psychiatrie & Psychotherapie

• Name: Kerstin Mayer
• Affiliation: Institut für medizinische Psychologie und Neurobiologie

Key inclusion & exclusion criteria

Inclusion criteria: 1 - Attention Deficit Disorder inattentive type or hyperactive type or combined type according to DSM-IV criteria.
2 - No additional serious physical, neurological, or psychiatric disorders with the exception of moderate depression and personality disorders excluding anti-social or borderline personality disorders.
3 - Full scale IQ > 80

Exclusion criteria: 1 - Self-reported diagnosis of the following current symptoms: Serious physical illness or chronic diseases such as lung disease, heart disease, diabetes, hypertension, and rheumatic diseases; Neurological disorders including Parkinson's disease, stroke, multiple sclerosis and epilepsy; indicated psychiatric disorders including bipolar disorder, psychosis, obsessive-compulsive disorder, chronic tics, Tourette syndrome, and suicidal behavior.
2 - Previous participation in another neurofeedback study.


Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

F90

Hyperkinetic disorders

Intervention(s)

Group 1: Neurofeedback therapy, 30 one hour sessions up to five times a week with 20 ADHD adults;
Method: Feedback of EEG slow cortical potentials (< 0.1Hz) on electrode position Cz. The extent of activation and deactivation in term of slow electrical positive or negative shifts is displayed online on a computer screen to the patient and allows the patient to learn regulation and control over their brain activity via operant conditioning.
Group 2: Neurofeedback therapy, 30 one hour sessions up to five times a week with 20 ADHD adults;
Method: Feedback of the oxygen level of the blood flow in the frontal lobe using near-infrared spectroscopy (NIRS). The extent of prefrontal activation in terms of changes in O2Hb concentration is displayed online on a computer screen to the patient and allows the patient to learn regulation and control over their brain activity via operant conditioning.
Group 3: Biofeedback therapy, 30 one hour sessions up to five times a week with 20 ADHD adults;
Method: Feedback of muscular activity in the shoulder muscles. The extent of tension and relaxation of the left and right musculus supraspinatus is displayed online on a computer screen to the patient and allows the patient to learn regulation and control over their muscle tension via operant conditioning.

Primary Outcome(s)

Change in ADHD Rating Scale (self-rated and third-party-rated) at pre treatment, after 15 sessions, after 30 sessions and at 6 months follow-up.

Secondary Outcome(s)

Assessment time points: before therapy = T1, after 15 sessions = T2, after 30 sessions = T3, after 6 months follow op = T4

Questionnaires:
- Wender ADHD interview - T1, T3, T4
- Becks Depression Index (BDI-II) - T1, T2, T3, T4
- Anxiety (STAI) - T1, T2, T3, T4
- Borderline Symptoms (BSL) - T1, T2, T3, T4

Behavioural tests:
- CFT-20-R IQ - T1, T3
- d2 attention test - T1, T3
Reaction and attention test:
- Reaction times - T1, T2, T3, T4
- Reaction time variability - T1, T2, T3, T4
- Error rates - T1, T2, T3, T4
- Wordfluency - T1, T2, T3, T4

Changes in Psychophysiology:
- EEG: Event related potentials, frequency bands activity - T1, T2, T3, T4
- NIRS: Blood oxygen level during cognitive performance - T1, T2, T3, T4

All these measurements compared to a healthy control group - T1, T3

Assessment of self-regulation ability over all 30 sessions

Source(s) of Monetary Support

Deutsche Forschungsgemeinschaft

Ethics review

Status: Approved
Approval date: 07/10/2010
Contact:

Results

• URL: http://drks.de/search/en/trial/DRKS00006767#studyResults