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

NCT ID: NCT01196910

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2020-09-30

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

Detailed Description

Attention deficit disorder in adults may be due to hypoactivity of prefrontal areas of the brain. Increasing the activity of these areas may help improve symptoms in many of these patients. In addition there is evidence as to dysfunction in both hemispheres of the brain, but it is difficult to determine the contribution of each hemisphere's pattern of activity to behavioral impairment. The purpose of this study is to use high-frequency DTMS to stimulate activity either on the left side of the prefrontal cortex (one arm), or on the right side (a second arm), to see if such stimulation improves attention, comparing to sham DTMS simulation (a third arm).

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stimulation over the left dorsolateral prefrontal cortex

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

Group Type: ACTIVE_COMPARATOR

treatment by HLPFC coil

Intervention Type: 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 right DLPFC

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

Group Type: ACTIVE_COMPARATOR

treatment by HLPFC coil

Intervention Type: 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.

Treatment with HLPFC coil simulator mode

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

Group Type: PLACEBO_COMPARATOR

treatment by HLPFC coil

Intervention Type: 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.

Interventions

treatment by HLPFC coil

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Pregnancy, or not using contraception.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brainsway

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Elissa Ash, Dr.

Role: CONTACT

elissaa@tasmc.health.gov.il

+972-3-6973328

References

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.

Reference Type: DERIVED

PMID: 34215144 (View on PubMed)

Other Identifiers

IBR-0014-00

Identifier Type: -

Identifier Source: org_study_id