Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders
1 other identifier
interventional
30
1 country
1
Brief Summary
- ADHD is one of the most common psychiatric disorders.
- While most of the attention is directed towards youth, 60% continue to suffer symptoms into adult life.
- Current treatment is effective, but 30% suffer side effects that lowers QOL, and 20% are non-responders.
- Known mechanism of pathophysiology includes hypoactive dopaminergic system, especially at right PFC.
- It is this study hypothesis that by stimulating the right PFC by TMS, it will be possible to alleviate ADHD symptoms.
- A 10 sessions of treatment will by applied on a randomly allocated group of patients, diagnosed with ADHD, in a 2:1 ratio: The first group will receive an actual TMS treatment, and the second group will receive a sham treatment.
- Improvement of objective and subjective ADHD scale will be examined.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2012
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
June 10, 2012
CompletedFirst Posted
Study publicly available on registry
June 13, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJune 19, 2012
June 1, 2012
2 years
June 10, 2012
June 18, 2012
Conditions
Keywords
Study Arms (2)
Treatment Group
ACTIVE COMPARATORSham group
SHAM COMPARATORSham TMS coil (same noise, minimal magnetic field)
Interventions
Superficial rTMS, directed at right PFC, power of 100% of MT, 10Hz for 4 seconds, intervals of 30 seconds, 42 trains.
Sham coil (minimal magnetic field, same noise and feeling)
Eligibility Criteria
You may qualify if:
- Age 18-50
- Established diagnosis of ADHD
- No C/I for TMS
- Has signed an informed consent form
You may not qualify if:
- Major Psychiatric disorders (Psychotic or Affective)
- Active use of drugs (4 weeks prior to participation)
- Neurologic disorder such as Epilepsy.
- No use of stimulants during the previous 7 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shalvata MHC
Hod HaSharon, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuval Bloch, MD
Shalvata MHC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2012
First Posted
June 13, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
June 19, 2012
Record last verified: 2012-06