Deep Transcranial Magnetic Stimulation (DTMS) as a Treatment for Attention Deficit Hyperactivity Disorder (ADHD) in Adults

NCT01196910 | Unknown Phase 1

• 1 other identifier: IBR-0014-00
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the effect of left or right high-frequency DTMS on ADHD symptoms, cognitive performance and decision-making ability of ADHD adults, and to compare this to the effect of sham DTMS on ADHD adults

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Conners' Adult ADHD Rating Scale

  Screening, at the end of three weeks of treatment, and for each of two follow-up meetings

Secondary Outcomes (1)

• Mindstreams Cognitive Tests

  Screening, at the end of three weeks of treatment, and for each of two follow-up meetings

Study Arms (3)

Stimulation over the left dorsolateral prefrontal cortex

ACTIVE COMPARATOR

Group A (fifteen subjects) - treatment by HLPFC coil high-frequency stimulation over the left dorsolateral prefrontal cortex (DLPFC).

Device: treatment by HLPFC coil

stimulation over the right DLPFC

ACTIVE COMPARATOR

Group B (fifteen subjects) - Treatment by HLPFC coil high-frequency stimulation over the right DLPFC.

Device: treatment by HLPFC coil

Treatment with HLPFC coil simulator mode

PLACEBO COMPARATOR

Group C (fifteen subjects) - Treatment with HLPFC coil simulator mode (sham).

Device: treatment by HLPFC coil

Interventions

treatment by HLPFC coil DEVICE

DTMS treatment will be given for 3 weeks, 5 days a week. Before each DTMS treatment, neural network excitation practice will be done using AttenGo software (AttenGo, Herzlia, Israel). Each treatment day: Follow-up to evaluate clinical side effects of treatment. Two additional meetings with DTMS treatment and follow-up will be held to evaluate the efficacy of treatment and side effects. The first will be four weeks after the end of the daily treatment phase; the second eight weeks after the end of the daily treatment phase.

Stimulation over the left dorsolateral prefrontal cortex; Treatment with HLPFC coil simulator mode; stimulation over the right DLPFC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18-65.
• Appropriate diagnosis of ADHD according to DSM-IV criteria:
• o DSM-IV criteria require not only that the ADHD symptoms be present now (self-report), but also to have been present in childhood (self-report)
• Subjects taking medications for attention deficit disorder will give their consent to stop the drugs from a week before the start of participation in the study, and during the daily treatment phase (four weeks total); subjects also will be asked not to take these medications 24 hours before participation in the review meetings (4 and 8 weeks after the end of the daily treatment phase).
• Subjects have given their written and oral consent to participate in research.

You may not qualify if:

• Any DSM-IV Axis I psychiatric disorder.
• Use of antipsychotic stabilizers; other than benzodiazepines if necessary to a daily dosage equivalent to 2 mg Lorazepam.
• History of lack of tolerance to TMS.
• Diagnosis of severe DSM-IV personality disorder.
• Current suicidal tendency.
• Uncontrolled high blood pressure
• History of epilepsy, seizures or fever convulsions.
• History of epilepsy or convulsions in first-degree relatives.
• A history of head injury or a stroke which caused deficits.
• History of metal in the head (outside the oral cavity).
• History of plastic or metal implants, including metallic particles in the eye, pacemaker, implanted hearing aid devices, use of neurostimulators, or any medical pump.
• A history of drug or alcohol misuse.
• People who lack judgment or are unable to communicate with the experimenters.
• Participation in any other medical research during the three months prior to the time of this experiment.
• Subject's inability to sign a consent form.

Sponsors & Collaborators

• Brainsway: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Related Publications (1)

• Bleich-Cohen M, Gurevitch G, Carmi N, Medvedovsky M, Bregman N, Nevler N, Elman K, Ginou A, Zangen A, Ash EL. A functional magnetic resonance imaging investigation of prefrontal cortex deep transcranial magnetic stimulation efficacy in adults with attention deficit/hyperactive disorder: A double blind, randomized clinical trial. Neuroimage Clin. 2021;30:102670. doi: 10.1016/j.nicl.2021.102670. Epub 2021 Apr 18.

  PMID: 34215144 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Elissa Ash, Dr.

CONTACT

+972-3-6973328; elissaa@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 9, 2010
• Study Start: July 1, 2011
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-01

Locations

IL (1)