- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01369264
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
Status
Avslutad
Intervention / Behandling
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
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Ontario
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Hamilton, Ontario, Kanada, L8N 3K7
- St. Joseph's Healthcare, Centre for Mountain Health Services
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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 |
|---|---|
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Experimentell: True Left High Frequency
True left high frequency repetitive transcranial magnetic stimulation
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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:
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Placebo-jämförare: Passive sham left high frequency
Passive sham left high frequency repetitive transcranial magnetic stimulation
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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:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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.
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The GMFA will be measured for 1 minutes after each rTMS train is delivered.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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.
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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.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
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
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 07-2827
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 .