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The Effect of Repetitive Transcranial Magnetic Stimulation on Brain Activity in Healthy Human Volunteers (ERP)

7 juni 2011 uppdaterad av: St. Joseph's Healthcare Hamilton

Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Brain Electrical Activity in Healthy Human Volunteers

The proposed study is designed to determine whether small changes in the positioning of a transcranial magnetic stimulation coil over the frontal parts of the brain cause different patterns of brain activation measured by electroencephalography (EEG) and quantitative EEG (QEEG).

Studieöversikt

Detaljerad beskrivning

A previously recorded MRI will be loaded into Brainsight, a stereotactic neuronavigation system specifically designed to be used with rTMS, and the scalp surface site overlying the centre of Brodmann area 46 in the dorsolateral prefrontal cortex (DLPFC) of both the left and right hemisphere will be identified and marked on a spandex swim cap placed on the subjects head over 31 EEG electrodes (notched to prevent eddy currents) placed at international 10-20 locations . Three trains of true 10 Hz (110% motor threshold (MT)] rTMS (one train each with duration=2,4, and 8 seconds) and 6 similar trains of sham rTMS (3 of active sham and 3 of inactive sham) will be delivered to the left hemisphere in Brodmann area 46 in random order. Eyes-closed QEEG power will be recorded across all leads over 10 second "blocks" for 1 minute after each 10 Hz stimulus to determine the distribution and time course of any changes in electrical potential and QEEG spectrum. The subjects will be asked to rate their mood and anxiety by placing a mark along 100 mm long Visual Analogue Scales for depression and anxiety after each stimulus train. We will also measure ERPs after 1 Hz stimulation to the right DLPFC (centre of Brodmann area 46). We will administer three 60-second trains of true 1 Hz rTMS (at 90%, 100% and 110% motor threshold), and six 60-second trains of sham rTMS (3 of "active" sham and 3 of "inactive" sham) with device intensity setting of 10 %, 30% and 50% motor threshold and coil tilted at 90 degrees away form the head. Part 2 (location testing): Twenty four to 48 hours later, the swim hat will be placed on the subject's head and the neuroanatomical landmarks reconfirmed using Brainsight. One true train and 1 inactive sham train of 10 Hz rTMS (10 Hz, 110% MT) will be delivered in random order to Brodmann area 46 and two other sites (in Brodmann areas 9 and 10). The rTMS train duration will be 8 seconds. The subjects will be asked to rate their mood and anxiety by placing a mark along 100 mm long Visual Analogue Scales for depression and anxiety after each stimulus train. The same procedure will be done over the right hemisphere using 1 Hz stimulation set at 110% motor threshold. True rTMS pulses at 1 Hz, or inactive sham rTMS pulses will be delivered in 60 second trains to the 3 sites as described above, but marked over the right DLPFC. QEEG activity will be recorded for 1 minute after each stimulus train. The subjects will be asked to rate their mood and anxiety by placing a mark along 100 mm long Visual Analogue Scales for depression and anxiety after each stimulus train. Diffusion Tensor Imaging: The 15 healthy subjects (18-65 years old) will also undergo diffusion tensor imaging (DTI) along with the MRI, which will add approximately 10 minutes to the MRI procedure. Following a routine brain imaging protocol whole brain DTI measurements will be conducted in each subject using a single shot spin echo EPI diffusion tensor imaging sequence.

Studietyp

Interventionell

Inskrivning (Faktisk)

17

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Ontario
      • Hamilton, Ontario, Kanada, L8N 3K7
        • St. Joseph's Healthcare, Centre for Mountain Health Services

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • age 18-65
  • male or female

Exclusion Criteria:

  • uncontrolled physical health problems
  • psychiatric illness
  • personal and/or family history of epilepsy/seizures
  • metal in the head or neck
  • recent head injury
  • pacemaker
  • pregnancy
  • alcohol/substance abuse within 3 months

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: True Left High Frequency
True left high frequency repetitive transcranial magnetic stimulation
10 Hz stimulation will be given at 110% motor threshold for 8 seconds to Brodmann areas 46, 9 and 10 in the left hemisphere. The coil will be held flat over the skull surface with the coil handle held at approximately 45 degrees to the floor
Andra namn:
  • Magstim super rapid left true 10 Hz
Placebo-jämförare: Passive sham left high frequency
Passive sham left high frequency repetitive transcranial magnetic stimulation
10 Hz stimulation will be given at 110% motor threshold for 8 seconds to Brodmann areas 46, 9 and 10 in the left hemisphere. The passive (inactive) coil will be held flat over the skull surface with the coil handle held at approximately 45 degrees to the floor. An active coil will be held vertically in a mechanical holder 50 cm behind the subject head and run at 10 Hz with an intensity set to 150% of motor threshold.
Andra namn:
  • Magstim super rapid left passive sham 10 Hz

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
The primary outcome measure will be global mean field amplitude (GMFA) before and after treatment with true or sham rTMS using a range of stimulus train durations and several stimulation sites.
Tidsram: The GMFA will be measured for 1 minutes after each rTMS train is delivered.
The GMFA will be measured for 1 minutes after each rTMS train is delivered.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Secondary outcome measures will include magnetically evoked response potentials in the multi-channel recorded EEG signals.
Tidsram: The L/R APR will be measured for 1 minute after each TMS train is delivered.

The magnetically evoked response potentials will be measured over the first 500 milliseconds after each TMS pulse.

We will also determine weather rTMS can produce measurable changes in left/right alpha power ratio (L/R APR). The L/R APR will be measured for 1 minute after each TMS train is delivered.

The L/R APR will be measured for 1 minute after each TMS train is delivered.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Gary Hasey, MD, St. Joseph's Health Care London

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2007

Primärt slutförande (Faktisk)

1 augusti 2010

Avslutad studie (Faktisk)

1 augusti 2010

Studieregistreringsdatum

Först inskickad

18 september 2010

Först inskickad som uppfyllde QC-kriterierna

7 juni 2011

Första postat (Uppskatta)

8 juni 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

8 juni 2011

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 juni 2011

Senast verifierad

1 juli 2007

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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